{"protocolSection":{"identificationModule":{"nctId":"NCT00062738","orgStudyIdInfo":{"id":"4381"},"organization":{"fullName":"Rutgers, The State University of New Jersey","class":"OTHER"},"briefTitle":"Treatment of Depression in Parkinson's Disease Trial","officialTitle":"Treatment of Depression in Patients With Parkinson's Disease"},"statusModule":{"statusVerifiedDate":"2015-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2003-06"},"primaryCompletionDateStruct":{"date":"2009-01","type":"ACTUAL"},"completionDateStruct":{"date":"2009-01","type":"ACTUAL"},"studyFirstSubmitDate":"2003-06-12","studyFirstSubmitQcDate":"2003-06-12","studyFirstPostDateStruct":{"date":"2003-06-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-12-05","resultsFirstSubmitQcDate":"2013-01-24","resultsFirstPostDateStruct":{"date":"2013-03-05","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-10-27","lastUpdatePostDateStruct":{"date":"2015-11-24","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Rutgers, The State University of New Jersey","class":"OTHER"},"collaborators":[{"name":"GlaxoSmithKline","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine, compared to placebo in patients with Parkinson's disease and depression.","detailedDescription":"Depression is the most common neuropsychiatric disorder found in patients with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and caregiver burden.\n\nDespite the adverse consequences of depression in patients with PD, there are virtually no empirical data to guide clinical treatment. This study will begin to answer some questions on the treatment of depression by testing a SSRI (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial.\n\nA total of 75 patients with PD will be randomized to each of the three arms in a balanced design."},"conditionsModule":{"conditions":["Parkinson Disease","Depression"],"keywords":["Parkinson's disease","Parkinson disease","depression","antidepressants","nortriptyline","paroxetine"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":52,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"nortriptyline","type":"EXPERIMENTAL","description":"drug","interventionNames":["Drug: Nortriptyline"]},{"label":"paroxetine","type":"EXPERIMENTAL","description":"drug","interventionNames":["Drug: paroxetine"]},{"label":"placebo","type":"PLACEBO_COMPARATOR","description":"placebo","interventionNames":["Other: placebo"]}],"interventions":[{"type":"DRUG","name":"paroxetine","description":"Paroxetine CR 12.5 - 25 mg q hs","armGroupLabels":["paroxetine"],"otherNames":["Paxil CR"]},{"type":"DRUG","name":"Nortriptyline","description":"nortriptyline 25 - 75 mg q hs","armGroupLabels":["nortriptyline"],"otherNames":["Pamelor"]},{"type":"OTHER","name":"placebo","description":"matching placebo","armGroupLabels":["placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Hamilton Depression Scale","description":"total score on HDRS (0-54 higher score is worse)","timeFrame":"8 weeks"}],"secondaryOutcomes":[{"measure":"Percent Responders","description":"Percent of patients who had a 50% decrease in total HDRS at 8 weeks","timeFrame":"8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"inclusion criteria:\n\n* Parkinson's disease without dementia.\n* Depression.\n* Males or females.\n\nexclusion criteria:\n\n* Psychosis\n* Heart block","healthyVolunteers":false,"sex":"ALL","minimumAge":"35 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Matthew Menza, M.D.","affiliation":"Rutgers, The State University of New Jersey","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Robert Wood Johnson Medical School","city":"New Brunswick","state":"New Jersey","zip":"08901","country":"United States","geoPoint":{"lat":40.48622,"lon":-74.45182}}]},"referencesModule":{"references":[{"pmid":"19092112","type":"RESULT","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":"20808132","type":"DERIVED","citation":"Dobkin RD, Menza M, Bienfait KL, Gara M, Marin H, Mark MH, Dicke A, Friedman J. Depression in Parkinson's disease: symptom improvement and residual symptoms after acute pharmacologic management. Am J Geriatr Psychiatry. 2011 Mar;19(3):222-9. doi: 10.1097/JGP.0b013e3181e448f7."},{"pmid":"20463113","type":"DERIVED","citation":"Dobkin RD, Menza M, Bienfait KL, Gara M, Marin H, Mark MH, Dicke A, Troster A. The impact of antidepressant treatment on cognitive functioning in depressed patients with Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2010 Spring;22(2):188-95. doi: 10.1176/jnp.2010.22.2.188."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Patients who met inclusion and not exclusion criteria were enrolled.","recruitmentDetails":"Patients were recruited between 10/2003 and 7/2007, from the RWJMS movement disorder clinic and advertising to local support groups.","groups":[{"id":"FG000","title":"Nortriptyline","description":"Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg."},{"id":"FG001","title":"Paroxetine","description":"Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg, based on investigator discretion. ."},{"id":"FG002","title":"Placebo","description":"Placebo was started at 1 pill and could be increased up to three pills, based on investigator discretion."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"17"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Nortriptyline","description":"Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg."},{"id":"BG001","title":"Paroxetine","description":"Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg."},{"id":"BG002","title":"Placebo","description":"Placebo was started at 1 pill and could be increased up to three pills."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"52"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"31"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"21"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"62.9","spread":"9.3"},{"groupId":"BG001","value":"62.8","spread":"8.1"},{"groupId":"BG002","value":"61.4","spread":"9.2"},{"groupId":"BG003","value":"62.2","spread":"8.7"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"25"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"27"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"52"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Hamilton Depression Scale","description":"total score on HDRS (0-54 higher score is worse)","populationDescription":"intent to treat - total patients in the arm","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Nortriptyline"},{"id":"OG001","title":"Paroxetine"},{"id":"OG002","title":"Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.84","spread":"6.2"},{"groupId":"OG001","value":"12.45","spread":"6.36"},{"groupId":"OG002","value":"15.81","spread":"5.78"}]}]}]},{"type":"SECONDARY","title":"Percent Responders","description":"Percent of patients who had a 50% decrease in total HDRS at 8 weeks","populationDescription":"intent to treat","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percent of patients who were responders","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Nortriptyline","description":"Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg."},{"id":"OG001","title":"Paroxetine","description":"Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg."},{"id":"OG002","title":"Placebo","description":"Placebo was started at 1 pill and could be increased up to three pills."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"24"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"For the responder analysis, an LOCF approach was used in which a clinical response was operationally defined as at least a 50% reduction in the HAM-D score from baseline to 8 weeks. Clinical response was cross-tabulated with treatment and Fisher exact test was used to distinguish differences among these groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.05","statisticalMethod":"Fisher Exact","paramType":"Odds Ratio (OR)","paramValue":"3.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.8","ciUpperLimit":"15.9"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.","eventGroups":[{"id":"EG000","title":"Nortriptyline","seriousNumAffected":0,"seriousNumAtRisk":17,"otherNumAffected":17,"otherNumAtRisk":17},{"id":"EG001","title":"Paroxetine","seriousNumAffected":1,"seriousNumAtRisk":18,"otherNumAffected":7,"otherNumAtRisk":18},{"id":"EG002","title":"Placebo","seriousNumAffected":2,"seriousNumAtRisk":17,"otherNumAffected":11,"otherNumAtRisk":17}],"seriousEvents":[{"term":"fainting","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"patient was hospitalized for fainting","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":18},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":17}]},{"term":"muscle rigidity","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"increased parkinsonism","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":18},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":17}]},{"term":"delirium","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":18},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":17}]}],"otherEvents":[{"term":"constipation","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":17},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":18},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":17}]},{"term":"dry mouth","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":17},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":18},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":17}]},{"term":"insomnia","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":18},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":17}]},{"term":"fatigue","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":18},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":17}]},{"term":"orthostatic hypotension","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":17},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":18},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":17}]},{"term":"dizziness","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":18},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":17}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"This was only an eight week trial with relatively few participants."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Matthew Menza, MD","organization":"UMDNJ - RWJMS","email":"menza@umdnj.edu","phone":"732-235-4440"}}},"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":"D009661","term":"Nortriptyline"}],"ancestors":[{"id":"D010880","term":"Piperidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D003986","term":"Dibenzocycloheptenes"},{"id":"D001567","term":"Benzocycloheptenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D011083","term":"Polycyclic Compounds"}]}},"hasResults":true}