{"protocolSection":{"identificationModule":{"nctId":"NCT00086190","orgStudyIdInfo":{"id":"R01NS046487","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01NS046487"},"organization":{"fullName":"University of Rochester","class":"OTHER"},"briefTitle":"Study of Antidepressants in Parkinson's Disease","officialTitle":"Study of Antidepressants in Parkinson's Disease","acronym":"SAD-PD"},"statusModule":{"statusVerifiedDate":"2013-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-06"},"primaryCompletionDateStruct":{"date":"2009-11","type":"ACTUAL"},"completionDateStruct":{"date":"2009-11","type":"ACTUAL"},"studyFirstSubmitDate":"2004-06-28","studyFirstSubmitQcDate":"2004-06-28","studyFirstPostDateStruct":{"date":"2004-06-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-01-11","resultsFirstSubmitQcDate":"2013-01-03","resultsFirstPostDateStruct":{"date":"2013-01-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-01-03","lastUpdatePostDateStruct":{"date":"2013-01-04","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Irene Richard","investigatorTitle":"Irene Richard, MD","investigatorAffiliation":"University of Rochester"},"leadSponsor":{"name":"University of Rochester","class":"OTHER"},"collaborators":[{"name":"National Institute of Neurological Disorders and Stroke (NINDS)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.","detailedDescription":"Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.\n\nThe purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.\n\nThis is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo."},"conditionsModule":{"conditions":["Parkinson Disease","Depression"],"keywords":["Parkinson disease","depression","Parkinson's disease","paroxetine","venlafaxine","antidepressant"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":115,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"paroxetine","type":"ACTIVE_COMPARATOR","description":"Paroxetine and venlafaxine will be compared to placebo over 12 weeks.","interventionNames":["Drug: paroxetine"]},{"label":"venlafaxine extended release","type":"ACTIVE_COMPARATOR","description":"Paroxetine and venlafaxine will be compared to placebo over 12 weeks.","interventionNames":["Drug: venlafaxine"]},{"label":"placebo","type":"PLACEBO_COMPARATOR","description":"Paroxetine and venlafaxine will be compared to placebo over 12 weeks.","interventionNames":["Other: placebo"]}],"interventions":[{"type":"DRUG","name":"paroxetine","description":"Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.","armGroupLabels":["paroxetine"],"otherNames":["Paxil"]},{"type":"DRUG","name":"venlafaxine","description":"Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.","armGroupLabels":["venlafaxine extended release"],"otherNames":["Effexor XR"]},{"type":"OTHER","name":"placebo","description":"an inactive substance","armGroupLabels":["placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Hamilton Depression Rating Scale (HAM-D) Scores","description":"Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"}],"secondaryOutcomes":[{"measure":"Change in Montgomery-Asberg Depression Rating Scale (MADRS)","description":"Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Beck Depression Inventory II (BDI-II)","description":"Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Geriatric Depression Rating Scale (GDS)","description":"Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Brief Psychiatric Rating Scale (BPRS)","description":"Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Unified Parkinson's Disease Rating Scale (UPDRS)","description":"Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Snaith Clinical Anxiety Scale (CAS)","description":"Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Pittsburgh Sleep Quality Index (PSQI)","description":"Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor","description":"Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor","description":"Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar","description":"Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall","description":"Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being","description":"Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Short Form 36 Health Survey - Mental Component Summary","description":"Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Short Form 36 Health Survey - Vitality","description":"Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Short Form 36 Health Survey - Role-Emotional","description":"Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"},{"measure":"Change in Short Form 36 Health Survey - Mental Health","description":"Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nTo be eligible you must be:\n\n* 30 years old or older\n* diagnosed with Parkinson's disease\n* experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping","healthyVolunteers":false,"sex":"ALL","minimumAge":"30 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Irene Richard, MD","affiliation":"University of Rochester","role":"PRINCIPAL_INVESTIGATOR"},{"name":"William McDonald, MD","affiliation":"Co-Principal Investigator--Emory University School of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of California San Francisco","city":"San Francisco","state":"California","zip":"94143","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}},{"facility":"University of Florida","city":"Gainesville","state":"Florida","zip":"32610","country":"United States","geoPoint":{"lat":29.65163,"lon":-82.32483}},{"facility":"University of Miami","city":"Miami","state":"Florida","zip":"33136","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Emory University School of Medicine","city":"Atlanta","state":"Georgia","zip":"30322","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"University of Kentucky","city":"Lexington","state":"Kentucky","zip":"40536","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","zip":"21218","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"University of Maryland","city":"Baltimore","state":"Maryland","zip":"21250","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue","city":"Boston","state":"Massachusetts","zip":"02215","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","zip":"63110","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"University of Rochester","city":"Rochester","state":"New York","zip":"14627","country":"United States","geoPoint":{"lat":43.15478,"lon":-77.61556}},{"facility":"Medical University of Ohio","city":"Toledo","state":"Ohio","country":"United States","geoPoint":{"lat":41.66394,"lon":-83.55521}},{"facility":"Oregon Health Sciences University","city":"Portland","state":"Oregon","zip":"97239","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"University of Tennessee-Memphis","city":"Memphis","state":"Tennessee","zip":"38163","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"Baylor College of Medicine, 6550 Fannin, Suite 1801","city":"Houston","state":"Texas","zip":"77030","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","zip":"22901","country":"United States","geoPoint":{"lat":38.02931,"lon":-78.47668}},{"facility":"London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road","city":"London","state":"Ontario","zip":"N6A 5A5","country":"Canada","geoPoint":{"lat":42.98339,"lon":-81.23304}},{"facility":"Hotel-Dieu Hospital-CHUM","city":"Montreal","state":"Quebec","zip":"H2W 1T8","country":"Canada","geoPoint":{"lat":45.50884,"lon":-73.58781}},{"facility":"University of Puerto Rico","city":"San Juan","zip":"00936","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}}]},"referencesModule":{"references":[{"pmid":"1536634","type":"BACKGROUND","citation":"Dooneief G, Mirabello E, Bell K, Marder K, Stern Y, Mayeux R. An estimate of the incidence of depression in idiopathic Parkinson's disease. Arch Neurol. 1992 Mar;49(3):305-7. doi: 10.1001/archneur.1992.00530270125028."},{"pmid":"9309555","type":"BACKGROUND","citation":"Liu CY, Wang SJ, Fuh JL, Lin CH, Yang YY, Liu HC. The correlation of depression with functional activity in Parkinson's disease. J Neurol. 1997 Aug;244(8):493-8. doi: 10.1007/s004150050131."},{"pmid":"10752569","type":"BACKGROUND","citation":"Kuopio AM, Marttila RJ, Helenius H, Toivonen M, Rinne UK. The quality of life in Parkinson's disease. Mov Disord. 2000 Mar;15(2):216-23. doi: 10.1002/1531-8257(200003)15:23.0.co;2-#."},{"pmid":"10501101","type":"BACKGROUND","citation":"Phillips P. Keeping depression at bay helps patients with Parkinson disease. JAMA. 1999 Sep 22-29;282(12):1118-9. No abstract available."},{"pmid":"11835440","type":"BACKGROUND","citation":"Global Parkinson's Disease Survey (GPDS) Steering Committee.. Factors impacting on quality of life in Parkinson's disease: results from an international survey. Mov Disord. 2002 Jan;17(1):60-7. doi: 10.1002/mds.10010."},{"pmid":"19092112","type":"BACKGROUND","citation":"Menza M, Dobkin RD, Marin H, Mark MH, Gara M, Buyske S, Bienfait K, Dicke A. A controlled trial of antidepressants in patients with Parkinson disease and depression. Neurology. 2009 Mar 10;72(10):886-92. doi: 10.1212/01.wnl.0000336340.89821.b3. Epub 2008 Dec 17."},{"pmid":"18311826","type":"BACKGROUND","citation":"Devos D, Dujardin K, Poirot I, Moreau C, Cottencin O, Thomas P, Destee A, Bordet R, Defebvre L. Comparison of desipramine and citalopram treatments for depression in Parkinson's disease: a double-blind, randomized, placebo-controlled study. Mov Disord. 2008 Apr 30;23(6):850-7. doi: 10.1002/mds.21966."},{"pmid":"12422059","type":"BACKGROUND","citation":"Yeragani VK, Roose S, Mallavarapu M, Radhakrishna RK, Pesce V. Major depression with ischemic heart disease: effects of paroxetine and nortriptyline on measures of nonlinearity and chaos of heart rate. Neuropsychobiology. 2002;46(3):125-35. doi: 10.1159/000066390."},{"pmid":"12242058","type":"BACKGROUND","citation":"Yeragani VK, Pesce V, Jayaraman A, Roose S. Major depression with ischemic heart disease: effects of paroxetine and nortriptyline on long-term heart rate variability measures. Biol Psychiatry. 2002 Sep 1;52(5):418-29. doi: 10.1016/s0006-3223(02)01394-x."},{"pmid":"10401446","type":"BACKGROUND","citation":"Nelson JC, Kennedy JS, Pollock BG, Laghrissi-Thode F, Narayan M, Nobler MS, Robin DW, Gergel I, McCafferty J, Roose S. Treatment of major depression with nortriptyline and paroxetine in patients with ischemic heart disease. Am J Psychiatry. 1999 Jul;156(7):1024-8. doi: 10.1176/ajp.156.7.1024."},{"pmid":"8866503","type":"BACKGROUND","citation":"Simons JA. Fluoxetine in Parkinson's disease. Mov Disord. 1996 Sep;11(5):581-2. doi: 10.1002/mds.870110517. No abstract available."},{"pmid":"8423889","type":"BACKGROUND","citation":"Steur EN. Increase of Parkinson disability after fluoxetine medication. Neurology. 1993 Jan;43(1):211-3. doi: 10.1212/wnl.43.1_part_1.211."},{"pmid":"7991139","type":"BACKGROUND","citation":"Jimenez-Jimenez FJ, Tejeiro J, Martinez-Junquera G, Cabrera-Valdivia F, Alarcon J, Garcia-Albea E. Parkinsonism exacerbated by paroxetine. Neurology. 1994 Dec;44(12):2406. doi: 10.1212/wnl.44.12.2406. No abstract available."},{"pmid":"8444831","type":"BACKGROUND","citation":"Salzman C. Pharmacologic treatment of depression in the elderly. J Clin Psychiatry. 1993 Feb;54 Suppl:23-8."},{"pmid":"2699465","type":"BACKGROUND","citation":"Altamura AC, De Novellis F, Guercetti G, Invernizzi G, Percudani M, Montgomery SA. Fluoxetine compared with amitriptyline in elderly depression: a controlled clinical trial. Int J Clin Pharmacol Res. 1989;9(6):391-6."},{"pmid":"3074861","type":"BACKGROUND","citation":"Feighner JP, Boyer WF, Meredith CH, Hendrickson G. An overview of fluoxetine in geriatric depression. Br J Psychiatry Suppl. 1988 Sep;(3):105-8. No abstract available."},{"pmid":"2258379","type":"BACKGROUND","citation":"Cohn CK, Shrivastava R, Mendels J, Cohn JB, Fabre LF, Claghorn JL, Dessain EC, Itil TM, Lautin A. Double-blind, multicenter comparison of sertraline and amitriptyline in elderly depressed patients. J Clin Psychiatry. 1990 Dec;51 Suppl B:28-33."},{"type":"BACKGROUND","citation":"Dubovsky S. Geriatric Neuropsychopharmacology. In: Coffey C, Cummings J, eds. Textbook of Geriatric Neuropsychiatry. Washington, DC: American Psychiatric Press, 1994:595-631."},{"pmid":"1531827","type":"BACKGROUND","citation":"Dunner DL, Cohn JB, Walshe T 3rd, Cohn CK, Feighner JP, Fieve RR, Halikas JP, Hartford JT, Hearst ED, Settle EC Jr, et al. Two combined, multicenter double-blind studies of paroxetine and doxepin in geriatric patients with major depression. J Clin Psychiatry. 1992 Feb;53 Suppl:57-60."},{"pmid":"2530766","type":"BACKGROUND","citation":"Guillibert E, Pelicier Y, Archambault JC, Chabannes JP, Clerc G, Desvilles M, Guibert M, Pagot R, Poisat JL, Thobie Y. A double-blind, multicentre study of paroxetine versus clomipramine in depressed elderly patients. Acta Psychiatr Scand Suppl. 1989;350:132-4. doi: 10.1111/j.1600-0447.1989.tb07192.x. No abstract available."},{"pmid":"10362442","type":"BACKGROUND","citation":"Hirschfeld RM. Efficacy of SSRIs and newer antidepressants in severe depression: comparison with TCAs. J Clin Psychiatry. 1999 May;60(5):326-35. doi: 10.4088/jcp.v60n0511."},{"pmid":"11775046","type":"BACKGROUND","citation":"Entsuah AR, Huang H, Thase ME. Response and remission rates in different subpopulations with major depressive disorder administered venlafaxine, selective serotonin reuptake inhibitors, or placebo. J Clin Psychiatry. 2001 Nov;62(11):869-77. doi: 10.4088/jcp.v62n1106."},{"pmid":"10757255","type":"BACKGROUND","citation":"Gentil V, Kerr-Correa F, Moreno R, D'Arrigo Busnello E, De Campos JA, Juruena MF, Lafer B, Moreno DH, De Cassia Rodrigues RL, Tiosso A, Benedictis E. Double-blind comparison of venlafaxine and amitriptyline in outpatients with major depression with or without melancholia. J Psychopharmacol. 2000 Mar;14(1):61-6. doi: 10.1177/026988110001400108."},{"type":"BACKGROUND","citation":"Applebaum PS, Grisso T. MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, FL: Professional Resource Press, 2001."},{"type":"BACKGROUND","citation":"American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Washington, DC, 1994."},{"type":"BACKGROUND","citation":"Spitzer RL, Gibbon M, Williams JBW. Structured clinical interview for Axis I DSM-IV disorders: Biometrics Research Department. New York State Psychiatric Institute 1994."},{"pmid":"1202204","type":"BACKGROUND","citation":"Folstein MF, Folstein SE, McHugh PR. \"Mini-mental state\". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available."},{"pmid":"14399272","type":"BACKGROUND","citation":"HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available."},{"pmid":"444788","type":"BACKGROUND","citation":"Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382."},{"pmid":"8991972","type":"BACKGROUND","citation":"Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13."},{"pmid":"7183759","type":"BACKGROUND","citation":"Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4."},{"pmid":"4089107","type":"BACKGROUND","citation":"Conners CK, Barkley RA. Rating scales and checklists for child psychopharmacology. Psychopharmacol Bull. 1985;21(4):809-43. No abstract available."},{"type":"BACKGROUND","citation":"Fahn S, Elton RL. Unified Parkinson's Disease Rating Scale. In: Fahn S, Marsden CD, Calne DB, Goldstein M, eds. Recent Developments in Parkinson's Disease. Florham Park, NJ: MacMillan Healthcare Information, 1992:153-163."},{"pmid":"19884574","type":"BACKGROUND","citation":"Uc EY, McDermott MP, Marder KS, Anderson SW, Litvan I, Como PG, Auinger P, Chou KL, Growdon JC; Parkinson Study Group DATATOP Investigators. Incidence of and risk factors for cognitive impairment in an early Parkinson disease clinical trial cohort. Neurology. 2009 Nov 3;73(18):1469-77. doi: 10.1212/WNL.0b013e3181bf992f."},{"pmid":"7273794","type":"BACKGROUND","citation":"Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981 Jun;2(2):93-113. doi: 10.1016/0197-2456(81)90001-5."},{"type":"BACKGROUND","citation":"Little RJA, Rubin DB. Statistical Analysis with Missing Data, Second Edition. Hoboken: John Wiley and Sons, 2002."},{"pmid":"16817205","type":"BACKGROUND","citation":"McDonald WM, Holtzheimer PE, Haber M, Vitek JL, McWhorter K, Delong M. Validity of the 30-item geriatric depression scale in patients with Parkinson's disease. Mov Disord. 2006 Oct;21(10):1618-22. doi: 10.1002/mds.21023."},{"pmid":"19092111","type":"BACKGROUND","citation":"Okun MS, Fernandez HH. Will tricyclic antidepressants make a comeback for depressed Parkinson disease patients? Neurology. 2009 Mar 10;72(10):868-9. doi: 10.1212/01.wnl.0000338145.24512.02. Epub 2008 Dec 17. No abstract available."},{"pmid":"19293925","type":"BACKGROUND","citation":"Brunoni AR, Lopes M, Kaptchuk TJ, Fregni F. Placebo response of non-pharmacological and pharmacological trials in major depression: a systematic review and meta-analysis. PLoS One. 2009;4(3):e4824. doi: 10.1371/journal.pone.0004824. Epub 2009 Mar 18."},{"pmid":"19455540","type":"BACKGROUND","citation":"Senn S, Julious S. Measurement in clinical trials: a neglected issue for statisticians? Stat Med. 2009 Nov 20;28(26):3189-209. doi: 10.1002/sim.3603."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"SAD-PD enrolled 115 participants from 20 centers in the US, Canada, and Puerto Rico from June 2005 through March 2009. Participants were recruited from movement disorder clinics. Eligible participants included men and women 30 years and older who were diagnosed with idiopathic PD, without dementia and who met depression criteria.","groups":[{"id":"FG000","title":"Paroxetine","description":"Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day."},{"id":"FG001","title":"Venlafaxine Extended Release","description":"Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day."},{"id":"FG002","title":"Placebo","description":"Placebo was made to match treatment options."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"39"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"33"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Moved","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Worsening depression","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Paroxetine","description":"Paroxetine and venlafaxine will be compared to placebo over 12 weeks."},{"id":"BG001","title":"Venlafaxine Extended Release","description":"Paroxetine and venlafaxine will be compared to placebo over 12 weeks."},{"id":"BG002","title":"Placebo","description":"Paroxetine and venlafaxine will be compared to placebo over 12 weeks."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"39"},{"groupId":"BG003","value":"115"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"65.2","spread":"9.8"},{"groupId":"BG001","value":"62.5","spread":"11.4"},{"groupId":"BG002","value":"62.7","spread":"11.0"},{"groupId":"BG003","value":"63.5","spread":"10.7"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"42"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"23"},{"groupId":"BG003","value":"73"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"12"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"35"},{"groupId":"BG003","value":"103"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Education beyond High School","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Beyond High School","categories":[{"measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"89"}]}]},{"title":"Not beyond High School","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"26"}]}]}]},{"title":"Marriage","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Married","categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"82"}]}]},{"title":"Not married","categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"33"}]}]}]},{"title":"Major Depression","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"73"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"42"}]}]}]},{"title":"Past Antidepressant Use","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"10"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"105"}]}]}]},{"title":"HAM-D Score","description":"Hamilton Depression Rating Scale. Ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Hamilton Depression Score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22.2","spread":"6.5"},{"groupId":"BG001","value":"21.2","spread":"6.0"},{"groupId":"BG002","value":"21.4","spread":"4.8"},{"groupId":"BG003","value":"21.6","spread":"5.8"}]}]}]},{"title":"MADRS Score","description":"Montgomery-Asberg Depression Rating Scale. Range 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"21.0","spread":"6.8"},{"groupId":"BG001","value":"19.4","spread":"7.9"},{"groupId":"BG002","value":"19.9","spread":"5.9"},{"groupId":"BG003","value":"20.1","spread":"6.9"}]}]}]},{"title":"GDS Score","description":"Geriatric Depression Scale. Range 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15.5","spread":"6.2"},{"groupId":"BG001","value":"15.1","spread":"5.8"},{"groupId":"BG002","value":"15.0","spread":"4.9"},{"groupId":"BG003","value":"15.2","spread":"5.6"}]}]}]},{"title":"BDI-II Score","description":"Beck Depression Inventory II. Range 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17.2","spread":"9.2"},{"groupId":"BG001","value":"17.1","spread":"9.1"},{"groupId":"BG002","value":"17.5","spread":"7.4"},{"groupId":"BG003","value":"17.3","spread":"8.6"}]}]}]},{"title":"Years since PD Onset","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.7","spread":"5.8"},{"groupId":"BG001","value":"7.4","spread":"4.2"},{"groupId":"BG002","value":"7.0","spread":"3.8"},{"groupId":"BG003","value":"7.0","spread":"4.6"}]}]}]},{"title":"Years since PD Diagnosis","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.2","spread":"5.9"},{"groupId":"BG001","value":"4.7","spread":"3.7"},{"groupId":"BG002","value":"4.9","spread":"3.6"},{"groupId":"BG003","value":"4.9","spread":"4.4"}]}]}]},{"title":"Hoehn and Yahr Stage","description":"As the stage rating increases, the severity of the disease increases. Ranges from 1.0 to 5.0.","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"1.0-1.5 (Unilateral Parkinson's Disease)","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"6"}]}]},{"title":"2.0-2.5 (Mild Bilateral Parkinson's Disease)","categories":[{"measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"31"},{"groupId":"BG003","value":"92"}]}]},{"title":"3.0-4.0 (Moderate to Severe Bilateral Parkinson's)","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"17"}]}]}]},{"title":"UPDRS Score","description":"Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum score = 0.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score","classes":[{"title":"Mental","categories":[{"measurements":[{"groupId":"BG000","value":"4.8","spread":"2.4"},{"groupId":"BG001","value":"5.2","spread":"1.9"},{"groupId":"BG002","value":"4.6","spread":"2.0"},{"groupId":"BG003","value":"4.9","spread":"2.1"}]}]},{"title":"Activities of Daily Living","categories":[{"measurements":[{"groupId":"BG000","value":"27.3","spread":"9.6"},{"groupId":"BG001","value":"26.8","spread":"12.3"},{"groupId":"BG002","value":"26.4","spread":"11.5"},{"groupId":"BG003","value":"26.8","spread":"11.1"}]}]},{"title":"Motor","categories":[{"measurements":[{"groupId":"BG000","value":"10.6","spread":"6.7"},{"groupId":"BG001","value":"11.4","spread":"7.4"},{"groupId":"BG002","value":"10.8","spread":"5.5"},{"groupId":"BG003","value":"10.9","spread":"6.5"}]}]},{"title":"Total","categories":[{"measurements":[{"groupId":"BG000","value":"42.7","spread":"14.9"},{"groupId":"BG001","value":"43.1","spread":"19.0"},{"groupId":"BG002","value":"41.7","spread":"15.9"},{"groupId":"BG003","value":"42.5","spread":"16.6"}]}]}]},{"title":"Schwab/England Activities of Daily Living Score (\"On\")","description":"Schwab and England Activities of Daily Living Scale (S/E ADL). Range 0-100%. Higher percentage indicates higher level of function and lower impact of disease on life activities.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"82.9","spread":"11.2"},{"groupId":"BG001","value":"80.3","spread":"14.6"},{"groupId":"BG002","value":"80.8","spread":"13.4"},{"groupId":"BG003","value":"81.3","spread":"13.1"}]}]}]},{"title":"Motor Fluctuations","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"69"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"46"}]}]}]},{"title":"PDQ-39 Total","description":"Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score on PDQ-39 Questionnaire","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36.8","spread":"16.3"},{"groupId":"BG001","value":"37.2","spread":"15.6"},{"groupId":"BG002","value":"39.6","spread":"14.8"},{"groupId":"BG003","value":"37.9","spread":"15.6"}]}]}]},{"title":"Short Form-36 Health Survey Scores","description":"Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score","classes":[{"title":"Physical Component Summary","categories":[{"measurements":[{"groupId":"BG000","value":"37.5","spread":"9.3"},{"groupId":"BG001","value":"36.2","spread":"10.3"},{"groupId":"BG002","value":"37.1","spread":"10.4"},{"groupId":"BG003","value":"36.9","spread":"10"}]}]},{"title":"Mental Component Summary","categories":[{"measurements":[{"groupId":"BG000","value":"41.4","spread":"8.8"},{"groupId":"BG001","value":"38.3","spread":"10.1"},{"groupId":"BG002","value":"40.0","spread":"9.3"},{"groupId":"BG003","value":"39.9","spread":"9.4"}]}]}]},{"title":"Snaith CAS","description":"Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.7","spread":"3.9"},{"groupId":"BG001","value":"7.8","spread":"4.5"},{"groupId":"BG002","value":"7.5","spread":"4.3"},{"groupId":"BG003","value":"7.3","spread":"4.2"}]}]}]},{"title":"Mini Mental State Examination Score","description":"Mini Mental State Examination (MMSE). Range 0-30. Higher score indicates better cognitive status. Score less than 9 = severe cognitive impairment, 10-20 moderate impairment, 21-24 mild impairment, 25 and greater considered normal.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.7","spread":"1.4"},{"groupId":"BG001","value":"28.9","spread":"1.8"},{"groupId":"BG002","value":"28.5","spread":"1.5"},{"groupId":"BG003","value":"28.7","spread":"1.6"}]}]}]},{"title":"BPRS Score","description":"Brief Psychiatric Rating Scale. Maximum score 126, minimum score 0. Higher score indicates greater psychiatric difficulties.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33.6","spread":"10.7"},{"groupId":"BG001","value":"35.7","spread":"8.9"},{"groupId":"BG002","value":"34.4","spread":"9.3"},{"groupId":"BG003","value":"34.6","spread":"9.6"}]}]}]},{"title":"Treatment of PD - Levodopa","description":"Participants taking Levodopa for treatment of Parkinson's Disease.","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Treatment - Yes","categories":[{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"32"},{"groupId":"BG003","value":"97"}]}]},{"title":"Treatment - No","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"18"}]}]}]},{"title":"Treatment of PD - Agonist","description":"Participants taking Agonist for treatment of Parkinson's Disease.","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Treatment - Yes","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"42"}]}]},{"title":"Treatment - No","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"73"}]}]}]},{"title":"Treatment for PD - Catechol O-methyltransferase Inhibitor","description":"Participants taking Catechol O-methyltransferase (COMT) Inhibitor for treatment of Parkinson's Disease.","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Treatment - Yes","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"29"}]}]},{"title":"Treatment - No","categories":[{"measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"86"}]}]}]},{"title":"Treatment of PD - Amantadine","description":"Participants taking Amantadine for treatment of Parkinson's Disease.","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Treatment - Yes","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"16"}]}]},{"title":"Treatment - No","categories":[{"measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"33"},{"groupId":"BG003","value":"99"}]}]}]},{"title":"Treatment of PD - Anticholinergic","description":"Participants taking Anticholinergic for treatment of Parkinson's Disease.","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Treatment - Yes","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"10"}]}]},{"title":"Treatment - No","categories":[{"measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"36"},{"groupId":"BG003","value":"105"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Hamilton Depression Rating Scale (HAM-D) Scores","description":"Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Change in HAM-D score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.0","spread":"1.3"},{"groupId":"OG001","value":"-11.0","spread":"1.4"},{"groupId":"OG002","value":"-6.8","spread":"1.3"}]}]}]},{"type":"SECONDARY","title":"Change in Montgomery-Asberg Depression Rating Scale (MADRS)","description":"Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in MADRS score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.6","spread":"1.2"},{"groupId":"OG001","value":"-10.9","spread":"1.3"},{"groupId":"OG002","value":"-6.6","spread":"1.2"}]}]}]},{"type":"SECONDARY","title":"Change in Beck Depression Inventory II (BDI-II)","description":"Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in BDI-II score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.7","spread":"1.1"},{"groupId":"OG001","value":"-9.6","spread":"1.2"},{"groupId":"OG002","value":"-5.2","spread":"1.1"}]}]}]},{"type":"SECONDARY","title":"Change in Geriatric Depression Rating Scale (GDS)","description":"Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in GDS score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.9","spread":"1.0"},{"groupId":"OG001","value":"-6.9","spread":"1.1"},{"groupId":"OG002","value":"-2.8","spread":"1.0"}]}]}]},{"type":"SECONDARY","title":"Change in Brief Psychiatric Rating Scale (BPRS)","description":"Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in BPRS score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.0","spread":"1.3"},{"groupId":"OG001","value":"-9.8","spread":"1.4"},{"groupId":"OG002","value":"-4.4","spread":"1.3"}]}]}]},{"type":"SECONDARY","title":"Change in Unified Parkinson's Disease Rating Scale (UPDRS)","description":"Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in UPDRS score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.7","spread":"2.1"},{"groupId":"OG001","value":"-7.0","spread":"2.3"},{"groupId":"OG002","value":"-4.3","spread":"2.0"}]}]}]},{"type":"SECONDARY","title":"Change in Snaith Clinical Anxiety Scale (CAS)","description":"Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in CAS score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.6","spread":"0.6"},{"groupId":"OG001","value":"-3.2","spread":"0.6"},{"groupId":"OG002","value":"-2.4","spread":"0.6"}]}]}]},{"type":"SECONDARY","title":"Change in Pittsburgh Sleep Quality Index (PSQI)","description":"Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in PQSI score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"0.4"},{"groupId":"OG001","value":"-2.6","spread":"0.5"},{"groupId":"OG002","value":"-1.1","spread":"0.4"}]}]}]},{"type":"SECONDARY","title":"Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor","description":"Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in UPDRS-motor score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.3","spread":"1.5"},{"groupId":"OG001","value":"-2.0","spread":"1.6"},{"groupId":"OG002","value":"-1.0","spread":"1.5"}]}]}]},{"type":"SECONDARY","title":"Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor","description":"Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in UPDRS-tremor score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.4","spread":"0.5"},{"groupId":"OG001","value":"0.5","spread":"0.5"},{"groupId":"OG002","value":"-0.6","spread":"0.5"}]}]}]},{"type":"SECONDARY","title":"Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar","description":"Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in UPDRS-Bulbar score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"0.3"},{"groupId":"OG001","value":"-1.4","spread":"0.3"},{"groupId":"OG002","value":"-0.5","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall","description":"Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in PDQ-39 score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.0","spread":"2.3"},{"groupId":"OG001","value":"-8.4","spread":"2.4"},{"groupId":"OG002","value":"-5.3","spread":"2.1"}]}]}]},{"type":"SECONDARY","title":"Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being","description":"Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in PDQ-39 Emotional score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-21.4","spread":"3.3"},{"groupId":"OG001","value":"-20.7","spread":"3.5"},{"groupId":"OG002","value":"-10.9","spread":"3.1"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form 36 Health Survey - Mental Component Summary","description":"Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in SF-36 mental score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.4","spread":"1.7"},{"groupId":"OG001","value":"9.5","spread":"1.8"},{"groupId":"OG002","value":"4.8","spread":"1.6"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form 36 Health Survey - Vitality","description":"Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in SF-36 vitality score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.5","spread":"3.1"},{"groupId":"OG001","value":"9.1","spread":"3.3"},{"groupId":"OG002","value":"4.7","spread":"2.9"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form 36 Health Survey - Role-Emotional","description":"Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in SF-36 Role score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.5","spread":"7.5"},{"groupId":"OG001","value":"26.9","spread":"8.0"},{"groupId":"OG002","value":"12.7","spread":"6.9"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form 36 Health Survey - Mental Health","description":"Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.","populationDescription":"115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in SF-36 Mental Health score","timeFrame":"from the beginning (0 weeks) to end (12 weeks) of the double-blind phase","groups":[{"id":"OG000","title":"Paroxetine","description":"Mean change in outcome measure from baseline for participants taking paroxetine."},{"id":"OG001","title":"Venlafaxine Extended Release","description":"Mean change in outcome measure from baseline for participants taking venlafaxine ER."},{"id":"OG002","title":"Placebo","description":"Mean change in outcome measure from baseline for participants taking placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.7","spread":"2.7"},{"groupId":"OG001","value":"17.4","spread":"2.8"},{"groupId":"OG002","value":"9.7","spread":"2.5"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Paroxetine","description":"Paroxetine and venlafaxine will be compared to placebo over 12 weeks.","seriousNumAffected":0,"seriousNumAtRisk":42,"otherNumAffected":10,"otherNumAtRisk":42},{"id":"EG001","title":"Venlafaxine Extended Release","description":"Paroxetine and venlafaxine will be compared to placebo over 12 weeks.","seriousNumAffected":0,"seriousNumAtRisk":34,"otherNumAffected":8,"otherNumAtRisk":34},{"id":"EG002","title":"Placebo","description":"Paroxetine and venlafaxine will be compared to placebo over 12 weeks.","seriousNumAffected":0,"seriousNumAtRisk":39,"otherNumAffected":9,"otherNumAtRisk":39}],"otherEvents":[{"term":"Insomnia","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":42},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":34},{"groupId":"EG002","numEvents":9,"numAffected":9,"numAtRisk":39}]},{"term":"Abnormal Dreaming","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":42},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":39}]},{"term":"Somnolence","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numEvents":8,"numAffected":8,"numAtRisk":42},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":34},{"groupId":"EG002","numEvents":5,"numAffected":5,"numAtRisk":39}]},{"term":"Diaphoresis","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":42},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":34},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":39}]},{"term":"Pruritis","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":34},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":39}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":42},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":34},{"groupId":"EG002","numEvents":5,"numAffected":5,"numAtRisk":39}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":42},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":34},{"groupId":"EG002","numEvents":5,"numAffected":5,"numAtRisk":39}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":34},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":39}]},{"term":"Sexual Dysfunction","organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numEvents":10,"numAffected":10,"numAtRisk":42},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":34},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":39}]},{"term":"Fatigue","organSystem":"General disorders","stats":[{"groupId":"EG000","numEvents":9,"numAffected":9,"numAtRisk":42},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":34},{"groupId":"EG002","numEvents":5,"numAffected":5,"numAtRisk":39}]},{"term":"Back Pain","organSystem":"General disorders","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":34},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":39}]},{"term":"Chest Pain","organSystem":"General disorders","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":34},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":39}]},{"term":"Hot Flushes","organSystem":"General disorders","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":42},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":39}]},{"term":"Tremor","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":42},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":34},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":39}]},{"term":"Dyskinesia","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":42},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":34},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":39}]},{"term":"Dizziness","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":34},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":39}]},{"term":"Headache","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":42},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":34},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":39}]},{"term":"Balance Difficulty","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":42},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":34},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":39}]},{"term":"Numbness/Parasthesia","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":39}]},{"term":"Parkinsonism Aggravated","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":34},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":39}]},{"term":"Hypertension","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":42},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":34},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":39}]},{"term":"Micturition Difficulty","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":42},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":39}]},{"term":"Weight Gain","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":34},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":39}]},{"term":"Upper Respiratory Infection","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":42},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":39}]},{"term":"Agitation","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":34},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":39}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":42},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":34},{"groupId":"EG002","numEvents":5,"numAffected":5,"numAtRisk":39}]},{"term":"Irritability","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":42},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":34},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":39}]},{"term":"Decreased Libido","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":34},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":39}]},{"term":"Marked Restlessness","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":42},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":34},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":39}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Irene H. Richard, MD","organization":"University of Rochester Medical Center","email":"irene_richard@urmc.rochester.edu","phone":"585-341-7500"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D010300","term":"Parkinson Disease"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D020734","term":"Parkinsonian Disorders"},{"id":"D001480","term":"Basal Ganglia Diseases"},{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D009069","term":"Movement Disorders"},{"id":"D000080874","term":"Synucleinopathies"},{"id":"D019636","term":"Neurodegenerative Diseases"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D017374","term":"Paroxetine"},{"id":"D000069470","term":"Venlafaxine Hydrochloride"}],"ancestors":[{"id":"D010880","term":"Piperidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D003511","term":"Cyclohexanols"},{"id":"D000441","term":"Hexanols"},{"id":"D005233","term":"Fatty Alcohols"},{"id":"D000438","term":"Alcohols"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D010627","term":"Phenethylamines"},{"id":"D005021","term":"Ethylamines"},{"id":"D000588","term":"Amines"},{"id":"D003510","term":"Cyclohexanes"},{"id":"D003516","term":"Cycloparaffins"},{"id":"D006840","term":"Hydrocarbons, Alicyclic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D008055","term":"Lipids"}]}},"hasResults":true}