{"protocolSection":{"identificationModule":{"nctId":"NCT00369343","orgStudyIdInfo":{"id":"3151A1-403"},"organization":{"fullName":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women","officialTitle":"A Multicenter, Randomized, 8-week, Double-blind, Placebo-controlled Study Followed by a 6-month Open-label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2012-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-09"},"primaryCompletionDateStruct":{"date":"2007-11","type":"ACTUAL"},"completionDateStruct":{"date":"2008-07","type":"ACTUAL"},"studyFirstSubmitDate":"2006-08-25","studyFirstSubmitQcDate":"2006-08-25","studyFirstPostDateStruct":{"date":"2006-08-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2008-11-26","resultsFirstSubmitQcDate":"2012-04-09","resultsFirstPostDateStruct":{"date":"2012-05-07","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-04-09","lastUpdatePostDateStruct":{"date":"2012-05-07","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal."},"conditionsModule":{"conditions":["Depression","Depressive Disorder","Depressive Disorder, Major"],"keywords":["Major Depressive Disorder","vasomotor symptoms","menopause","diabetic neuropathy","fibromyalgia"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":381,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"A","type":"EXPERIMENTAL","interventionNames":["Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)"]},{"label":"B","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)","description":"DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks","armGroupLabels":["A"]},{"type":"DRUG","name":"Placebo","description":"Placebo, daily (QD), tablet form, treatment period up to 8 weeks","armGroupLabels":["B"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17","timeFrame":"Baseline to 8 weeks"}],"secondaryOutcomes":[{"measure":"Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score","description":"CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).","timeFrame":"8 weeks"},{"measure":"Percentage of Patients Achieving Remission","description":"Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.","timeFrame":"8 weeks"},{"measure":"Percentage of Patients Achieving Response to Treatment","description":"A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.","timeFrame":"8 weeks"},{"measure":"Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8","description":"The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.","timeFrame":"Baseline to 8 weeks"},{"measure":"Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8","description":"EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.","timeFrame":"Baseline to 8 weeks"},{"measure":"Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.","timeFrame":"open label baseline and 6 months"},{"measure":"Clinical Global Impression Improvement (CGI-I) Score","description":"CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)","timeFrame":"6 months"},{"measure":"Percentage of Patients Achieving Remission","description":"Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.","timeFrame":"6 months"},{"measure":"Percentage of Patients Achieving a Response to Treatment","description":"A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.","timeFrame":"6 months"},{"measure":"Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months","description":"The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.","timeFrame":"open label baseline to 6 months"},{"measure":"Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months","description":"EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.","timeFrame":"open label baseline to 6 months"},{"measure":"Discontinuation-Emergent Signs and Symptoms (DESS) Total Score","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of \"new symptoms\" and \"old (but worse) symptoms\" (1) and 0 for \"old and unchanged symptom,\" \"absent,\" or \"old symptom but improved\" for a total possible range of 0 to 43. A higher score indicates more symptoms.","timeFrame":"6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive.\n* A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified International Neuropsychiatric Interview (MINI).\n* Montgomery-Asberg Depression Rating Scale (MADRS) total score \\> or = 22 at the screening and baseline visit.\n\nExclusion Criteria:\n\n* Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.\n* Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.\n* A history or active presence of clinically important medical disease.\n\nAdditional criteria apply.","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"40 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Medical Monitor","affiliation":"Wyeth is now a wholly owned subsidiary of Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"city":"Birmingham","state":"Alabama","zip":"35226","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"city":"Little Rock","state":"Arkansas","zip":"72223","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"city":"Springdale","state":"Arkansas","zip":"72762","country":"United States","geoPoint":{"lat":36.18674,"lon":-94.12881}},{"city":"Palo Alto","state":"California","zip":"94305","country":"United States","geoPoint":{"lat":37.44188,"lon":-122.14302}},{"city":"San Diego","state":"California","zip":"92103","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"city":"New 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Deer","state":"Wisconsin","zip":"53223","country":"United States","geoPoint":{"lat":43.16334,"lon":-87.96453}}]},"referencesModule":{"references":[{"pmid":"25860107","type":"DERIVED","citation":"Kornstein SG, Clayton AH, Bao W, Guico-Pabia CJ. A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. J Womens Health (Larchmt). 2015 Apr;24(4):281-90. doi: 10.1089/jwh.2014.4900."},{"pmid":"20797382","type":"DERIVED","citation":"Kornstein SG, Jiang Q, Reddy S, Musgnung JJ, Guico-Pabia CJ. Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2010 Aug;71(8):1088-96. doi: 10.4088/JCP.10m06018blu."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Patients were screened over 4 weeks.","recruitmentDetails":"Patients were recruited in the United States from September 2006 to September 2007.","groups":[{"id":"FG000","title":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"FG001","title":"Placebo","description":"Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."}],"periods":[{"title":"Double-blind Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"256"},{"groupId":"FG001","numSubjects":"125"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"212"},{"groupId":"FG001","numSubjects":"109"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"16"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Failed to return","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Protocol deviation","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Open-label Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"212"},{"groupId":"FG001","numSubjects":"109"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"79"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"30"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Failed to return","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"inadvertently reported study completers","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lack of continuance tolerability","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"did not take study drug","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"BG001","title":"Placebo","description":"Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"256"},{"groupId":"BG001","value":"125"},{"groupId":"BG002","value":"381"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"52.01","spread":"6.50"},{"groupId":"BG001","value":"52.56","spread":"7.17"},{"groupId":"BG002","value":"52.19","spread":"6.72"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"256"},{"groupId":"BG001","value":"125"},{"groupId":"BG002","value":"381"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17","populationDescription":"Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, who took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.","reportingStatus":"POSTED","anticipatedPostingDate":"2008-11","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on scale","timeFrame":"Baseline to 8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Placebo","description":"Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"157"},{"groupId":"OG001","value":"81"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.64","spread":"0.53"},{"groupId":"OG001","value":"-8.33","spread":"0.74"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Models Repeated Measures (MMRM) used baseline as a covariate and factors for center, week and treatment.","paramType":"Mean Difference (Final Values)","paramValue":"4.32","ciPctValue":"95","ciLowerLimit":"2.53","ciUpperLimit":"6.11","estimateComment":"DVS SR adjusted mean change minus placebo adjusted mean change."}]},{"type":"SECONDARY","title":"Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score","description":"CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).","populationDescription":"Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Placebo","description":"Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"186"},{"groupId":"OG001","value":"97"}]}],"classes":[{"title":"1 (very much improved)","categories":[{"measurements":[{"groupId":"OG000","value":"42.5"},{"groupId":"OG001","value":"22.7"}]}]},{"title":"2 (much improved)","categories":[{"measurements":[{"groupId":"OG000","value":"25.3"},{"groupId":"OG001","value":"18.6"}]}]},{"title":"3 (minimally improved)","categories":[{"measurements":[{"groupId":"OG000","value":"16.7"},{"groupId":"OG001","value":"17.5"}]}]},{"title":"4 (no change)","categories":[{"measurements":[{"groupId":"OG000","value":"13.4"},{"groupId":"OG001","value":"32.0"}]}]},{"title":"5 (minimally worse)","categories":[{"measurements":[{"groupId":"OG000","value":"1.1"},{"groupId":"OG001","value":"7.2"}]}]},{"title":"6 (much worse)","categories":[{"measurements":[{"groupId":"OG000","value":"0.5"},{"groupId":"OG001","value":"2.1"}]}]},{"title":"7 (very much worse)","categories":[{"measurements":[{"groupId":"OG000","value":"0.5"},{"groupId":"OG001","value":"0.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"DVS SR compared to Placebo for CGI-I scores of either 1 (very much improved) or 2 (much improved).","statisticalMethod":"Cochran-Mantel-Haenszel"}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving Remission","description":"Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.","populationDescription":"Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).","reportingStatus":"POSTED","anticipatedPostingDate":"2009-07","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Placebo","description":"Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"186"},{"groupId":"OG001","value":"98"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38.2"},{"groupId":"OG001","value":"22.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.008","pValueComment":"DVS SR compared with Placebo.","statisticalMethod":"Chi-squared","statisticalComment":"Logistic regression model with treatment and site as factors and baseline score as a covariate.","paramType":"Odds Ratio (OR)","paramValue":"2.132","ciPctValue":"95","ciLowerLimit":"1.22","ciUpperLimit":"3.74","estimateComment":"Adjusted odds ratio of DVS SR to Placebo. Odds ratio adjusted for baseline, treatment and site."}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving Response to Treatment","description":"A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.","populationDescription":"Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Placebo","description":"Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"186"},{"groupId":"OG001","value":"98"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"58.6"},{"groupId":"OG001","value":"31.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"DVS SR compared with Placebo.","statisticalMethod":"Chi-squared","statisticalComment":"Logistic regression model with treatment and site as factors and baseline score as a covariate.","paramType":"Odds Ratio (OR)","paramValue":"3.125","ciPctValue":"95","ciLowerLimit":"1.85","ciUpperLimit":"5.27","estimateComment":"Adjusted odds ratio of DVS SR to Placebo. Odd ratio adjusted for baseline, treatment and site."}]},{"type":"SECONDARY","title":"Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8","description":"The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.","populationDescription":"Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on scale","timeFrame":"Baseline to 8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Placebo","description":"Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"81"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.62","spread":"0.44"},{"groupId":"OG001","value":"-5.89","spread":"0.62"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"2.74","ciPctValue":"95","ciLowerLimit":"1.24","ciUpperLimit":"4.23","estimateComment":"Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score."}]},{"type":"SECONDARY","title":"Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8","description":"EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.","populationDescription":"Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on scale","timeFrame":"Baseline to 8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Placebo","description":"Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"81"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.18","spread":"0.02"},{"groupId":"OG001","value":"0.06","spread":"0.02"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Mixed Model Repeated Measures (MMRM) with treatment and site as factors and baseline as covariate.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.12","ciPctValue":"95","ciLowerLimit":"-0.18","ciUpperLimit":"-0.06","estimateComment":"Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score."}]},{"type":"SECONDARY","title":"Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.","populationDescription":"Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on scale","timeFrame":"open label baseline and 6 months","groups":[{"id":"OG000","title":"DVS SR / DVS SR","description":"Patients were in the DVS SR arm during both the double-blind and open-label phase."},{"id":"OG001","title":"Placebo / DVS SR","description":"Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"103"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.52","spread":"7.17"},{"groupId":"OG001","value":"-12.45","spread":"6.85"}]}]}]},{"type":"SECONDARY","title":"Clinical Global Impression Improvement (CGI-I) Score","description":"CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)","populationDescription":"Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on scale","timeFrame":"6 months","groups":[{"id":"OG000","title":"DVS SR / DVS SR","description":"Patients were in the DVS SR arm during both the double-blind and open-label phase."},{"id":"OG001","title":"Placebo / DVS SR","description":"Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"208"},{"groupId":"OG001","value":"103"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.55","spread":"1.00"},{"groupId":"OG001","value":"1.56","spread":"0.99"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving Remission","description":"Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.","populationDescription":"Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"6 months","groups":[{"id":"OG000","title":"DVS SR / DVS SR","description":"Patients were in the DVS SR arm during both the double-blind and open-label phase."},{"id":"OG001","title":"Placebo / DVS SR","description":"Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"103"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"55.6"},{"groupId":"OG001","value":"48.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving a Response to Treatment","description":"A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.","populationDescription":"Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"NUMBER","unitOfMeasure":"percentage of patients responding","timeFrame":"6 months","groups":[{"id":"OG000","title":"DVS SR / DVS SR","description":"Patients were in the DVS SR arm during both the double-blind and open-label phase."},{"id":"OG001","title":"Placebo / DVS SR","description":"Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"103"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"70.5"},{"groupId":"OG001","value":"66.0"}]}]}]},{"type":"SECONDARY","title":"Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months","description":"The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.","populationDescription":"Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on scale","timeFrame":"open label baseline to 6 months","groups":[{"id":"OG000","title":"DVS SR / DVS SR","description":"Patients were in the DVS SR arm during both the double-blind and open-label phase."},{"id":"OG001","title":"Placebo / DVS SR","description":"Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"103"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-10.95","spread":"6.90"},{"groupId":"OG001","value":"-10.38","spread":"5.64"}]}]}]},{"type":"SECONDARY","title":"Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months","description":"EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.","populationDescription":"Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on scale","timeFrame":"open label baseline to 6 months","groups":[{"id":"OG000","title":"DVS SR / DVS SR","description":"Patients were in the DVS SR arm during both the double-blind and open-label phase."},{"id":"OG001","title":"Placebo / DVS SR","description":"Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"208"},{"groupId":"OG001","value":"102"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.19","spread":"0.26"},{"groupId":"OG001","value":"0.22","spread":"0.31"}]}]}]},{"type":"SECONDARY","title":"Discontinuation-Emergent Signs and Symptoms (DESS) Total Score","description":"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of \"new symptoms\" and \"old (but worse) symptoms\" (1) and 0 for \"old and unchanged symptom,\" \"absent,\" or \"old symptom but improved\" for a total possible range of 0 to 43. A higher score indicates more symptoms.","populationDescription":"Open-label (OL) safety population: Patients completed double-blind and continued in OL with ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with \\<4 wks therapy. Patients analyzed varied by time (0mg, 100mg, 200mg): Early Termination (n=9,98,207); Taper week 1 (n=4,76,193); Taper week 2 (n=5,75,195); Post-taper (n=5,71,192)","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on scale","timeFrame":"6 months","groups":[{"id":"OG000","title":"0 mg","description":"Placebo"},{"id":"OG001","title":"100 mg","description":"DVS SR 100mg dosage was reduced to DVS SR 50mg for 7 days."},{"id":"OG002","title":"200 mg","description":"DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"98"},{"groupId":"OG002","value":"207"}]}],"classes":[{"title":"End of 8 week DB / OL phase or early termination","categories":[{"measurements":[{"groupId":"OG000","value":"4.00","spread":"5.05"},{"groupId":"OG001","value":"2.07","spread":"4.03"},{"groupId":"OG002","value":"1.27","spread":"3.40"}]}]},{"title":"Taper week 1","categories":[{"measurements":[{"groupId":"OG000","value":"2.00","spread":"2.16"},{"groupId":"OG001","value":"3.32","spread":"4.35"},{"groupId":"OG002","value":"2.47","spread":"3.61"}]}]},{"title":"Taper week 2","categories":[{"measurements":[{"groupId":"OG000","value":"1.40","spread":"3.13"},{"groupId":"OG001","value":"5.29","spread":"5.96"},{"groupId":"OG002","value":"3.76","spread":"4.71"}]}]},{"title":"Post-taper","categories":[{"measurements":[{"groupId":"OG000","value":"0.60","spread":"0.89"},{"groupId":"OG001","value":"1.41","spread":"2.18"},{"groupId":"OG002","value":"2.46","spread":"3.97"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"100mg vs. Placebo (0mg) post 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for 8 weeks","seriousNumAffected":2,"otherNumAffected":94},{"id":"EG002","title":"Open-label DVS SR/ DVS SR","description":"Patients were in the DVS SR arm during both the double-blind and open-label phase.","seriousNumAffected":12,"otherNumAffected":198},{"id":"EG003","title":"Open-label Placebo/DVS SR","description":"Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.","seriousNumAffected":2,"otherNumAffected":97}],"seriousEvents":[{"term":"Hypertension","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":125},{"groupId":"EG002","numAffected":0,"numAtRisk":208},{"groupId":"EG003","numAffected":0,"numAtRisk":103}]},{"term":"Skin carcinoma","organSystem":"Skin and subcutaneous tissue 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