{"protocolSection":{"identificationModule":{"nctId":"NCT00406640","orgStudyIdInfo":{"id":"3151A1-402"},"organization":{"fullName":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women","officialTitle":"A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2023-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-12"},"primaryCompletionDateStruct":{"date":"2008-02","type":"ACTUAL"},"completionDateStruct":{"date":"2008-10","type":"ACTUAL"},"studyFirstSubmitDate":"2006-11-29","studyFirstSubmitQcDate":"2006-11-29","studyFirstPostDateStruct":{"date":"2006-12-04","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-02-27","resultsFirstSubmitQcDate":"2010-05-26","resultsFirstPostDateStruct":{"date":"2010-06-29","type":"ESTIMATED"},"lastUpdateSubmitDate":"2023-12-07","lastUpdatePostDateStruct":{"date":"2023-12-28","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Wyeth (Registry Contact: Clinical Trial Registry Specialist)","oldOrganization":"Wyeth"},"leadSponsor":{"name":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"}},"descriptionModule":{"briefSummary":"Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are postmenopausal."},"conditionsModule":{"conditions":["Depression","Depressive Disorder","Depressive Disorder, Major"],"keywords":["MDD","Major Depressive Disorder","Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":595,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"A","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Desvenlafaxine succinate sustained-release (DVS SR)"]},{"label":"B","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Escitalopram"]}],"interventions":[{"type":"DRUG","name":"Desvenlafaxine succinate sustained-release (DVS SR)","description":"flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.","armGroupLabels":["A"]},{"type":"DRUG","name":"Escitalopram","description":"Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.","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 either a 3 point (0 to 2) or a 5 point scale (0 to 4) with 0=none/absent and 4=most severe,for a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17.","timeFrame":"Baseline and 8 weeks"}],"secondaryOutcomes":[{"measure":"Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)","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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","timeFrame":"8 weeks"},{"measure":"Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)","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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","timeFrame":"8 weeks"},{"measure":"Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks","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":"Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week","description":"CGI-S is a global rating scale that measures the severity of a patient's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with patients who have the same diagnosis (1= normal; 7= extremely ill).","timeFrame":"Baseline and 8 weeks"},{"measure":"Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score","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 total score minus baseline adjusted mean total score.","timeFrame":"Baseline and Week 8"},{"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 and week 8"},{"measure":"Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)","description":"Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if the response was maintained. 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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","timeFrame":"6 months"},{"measure":"Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)","description":"Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if remission was achieved. 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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","timeFrame":"6 months"},{"measure":"Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase","description":"Patients achieving a response to treatment (Responders) at the end of the 8-week acute double blind (DB) phase continued into a 6-month DB phase. Responders without remission at 8 weeks were assessed for remission status during the 6-month continuation. Remission defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale assessing 17 items characteristically associated with major depression. Individual items scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","timeFrame":"6 months"},{"measure":"Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase","description":"Patients who didn't achieve a response to treatment at the end of the 8-week acute double blind phase entered into an OL treatment phase with DVS SR for 6 months and were evaluated to see if a response was achieved. 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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","timeFrame":"6 months"},{"measure":"Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase","description":"Patients who did not achieve a response to treatment at the end of the 8-week acute double blind phase entered into an open label (OL) treatment phase with DVS SR for 6 months and were evaluated to see if remission was achieved. 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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","timeFrame":"6 months"},{"measure":"Discontinuation-Emergent Signs and Symptoms (DESS) Total Score","description":"DESS is 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 that appeared during tapering of the test article. A higher score indicates more symptoms. The DESS score was assessed by status of taper.","timeFrame":"6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 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 MINI 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 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Open-label treatment with desvenlafaxine in postmenopausal women with major depressive disorder not responding to acute treatment with desvenlafaxine or escitalopram. CNS Drugs. 2011 Mar;25(3):227-38. doi: 10.2165/11586460-000000000-00000."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects were screened up to 4 weeks.","recruitmentDetails":"Subjects were recruited in Argentina, Chile, Colombia, Mexico and the United States from December 2006 to January 2008.","groups":[{"id":"FG000","title":"Desvenlafaxine Succinate Sustained-release (DVS SR)","description":"Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"FG001","title":"Escitalopram","description":"Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved \\> 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days."}],"periods":[{"title":"Acute Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"296"},{"groupId":"FG001","numSubjects":"299"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"245"},{"groupId":"FG001","numSubjects":"256"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"43"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"Failed to Return","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to 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Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"non-compliance","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"7"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Desvenlafaxine Succinate Sustained-release (DVS SR)","description":"Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"BG001","title":"Escitalopram","description":"Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved \\> 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"296"},{"groupId":"BG001","value":"299"},{"groupId":"BG002","value":"595"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.78","spread":"6.13"},{"groupId":"BG001","value":"56.15","spread":"6.25"},{"groupId":"BG002","value":"55.97","spread":"6.19"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"296"},{"groupId":"BG001","value":"299"},{"groupId":"BG002","value":"595"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"211"},{"groupId":"BG001","value":"219"},{"groupId":"BG002","value":"430"}]}]},{"title":"Mexico","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"19"}]}]},{"title":"Argentina","categories":[{"measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"85"}]}]},{"title":"Chile","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"20"}]}]},{"title":"Colombia","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"41"}]}]}]}]},"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 either a 3 point (0 to 2) or a 5 point scale (0 to 4) with 0=none/absent and 4=most severe,for a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17.","populationDescription":"Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on scale","timeFrame":"Baseline and 8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-release (DVS SR)","description":"Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Escitalopram","description":"Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved \\> 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"203"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.63","spread":"0.42"},{"groupId":"OG001","value":"-14.30","spread":"0.40"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR compared with ESC","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.243","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.","paramType":"Mean Difference (Final Values)","paramValue":"0.67","ciPctValue":"95","ciLowerLimit":"-0.46","ciUpperLimit":"1.81","estimateComment":"DVS SR adjusted mean change minus ESC adjusted mean change."}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)","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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","populationDescription":"Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-release (DVS SR)","description":"Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Escitalopram","description":"Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved \\> 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"224"},{"groupId":"OG001","value":"237"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"64.3"},{"groupId":"OG001","value":"73.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR compared with ESC.","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.077","statisticalMethod":"Chi-squared","statisticalComment":"Logistic regression model with treatment and site as factors and baseline score as a covariant.","paramType":"Odds Ratio (OR)","paramValue":"0.608","ciPctValue":"95","ciLowerLimit":"0.40","ciUpperLimit":"0.92","estimateComment":"Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site."}]},{"type":"SECONDARY","title":"Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)","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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","populationDescription":"Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of patients","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-release (DVS SR)","description":"Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Escitalopram","description":"Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved \\> 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"224"},{"groupId":"OG001","value":"237"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37.9"},{"groupId":"OG001","value":"48.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR compared with ESC.","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0054","statisticalMethod":"Chi-squared","statisticalComment":"Logistic regression model with treatment and site as factors and baseline score as a covariant.","paramType":"Odds Ratio (OR)","paramValue":"0.571","ciPctValue":"95","ciLowerLimit":"0.39","ciUpperLimit":"0.85","estimateComment":"Estimated odds ratio of DVS SR to ESC. Odds ratio adjusted for baseline, treatment and site."}]},{"type":"SECONDARY","title":"Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks","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":"Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-release (DVS SR)","description":"Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Escitalopram","description":"Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved \\> 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"203"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.93","spread":"0.08"},{"groupId":"OG001","value":"1.81","spread":"0.07"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR compared with ESC","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.260","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.","paramType":"Mean Difference (Final Values)","paramValue":"0.12","ciPctValue":"95","ciLowerLimit":"-0.09","ciUpperLimit":"0.33","estimateComment":"DVS SR minus ESC adjusted mean"}]},{"type":"SECONDARY","title":"Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week","description":"CGI-S is a global rating scale that measures the severity of a patient's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with patients who have the same diagnosis (1= normal; 7= extremely ill).","populationDescription":"Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on scale","timeFrame":"Baseline and 8 weeks","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-release (DVS SR)","description":"Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Escitalopram","description":"Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved \\> 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"203"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.09","spread":"0.09"},{"groupId":"OG001","value":"-2.22","spread":"0.08"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.239","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.","paramType":"Mean Difference (Final Values)","paramValue":"0.14","ciPctValue":"95","ciLowerLimit":"-0.09","ciUpperLimit":"0.37","estimateComment":"DVS SR minus ESC adjusted mean"}]},{"type":"SECONDARY","title":"Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score","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 total score minus baseline adjusted mean total score.","populationDescription":"Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on scale","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-release (DVS SR)","description":"Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Escitalopram","description":"Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved \\> 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"203"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.37","spread":"0.42"},{"groupId":"OG001","value":"-11.73","spread":"0.40"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR compared to ESC","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.516","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.","paramType":"Mean Difference (Net)","paramValue":"0.37","ciPctValue":"95","ciLowerLimit":"-0.75","ciUpperLimit":"1.49","estimateComment":"DVS SR adjusted mean change minus ESC adjusted mean change."}]},{"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":"Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on scale","timeFrame":"Baseline and week 8","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate Sustained-release (DVS SR)","description":"Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Escitalopram","description":"Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved \\> 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"179"},{"groupId":"OG001","value":"189"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.25","spread":"0.02"},{"groupId":"OG001","value":"0.24","spread":"0.02"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR compared to ESC","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.635","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) with treatment, time and site as factors and baseline as covariant.","paramType":"Mean Difference (Net)","paramValue":"0.01","ciPctValue":"95","ciLowerLimit":"-0.03","ciUpperLimit":"0.06","estimateComment":"DVS SR adjusted mean change minus ESC adjusted mean change"}]},{"type":"SECONDARY","title":"Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)","description":"Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if the response was maintained. 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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","populationDescription":"All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-04","paramType":"NUMBER","unitOfMeasure":"percentage of responders","timeFrame":"6 months","groups":[{"id":"OG000","title":"DVS SR Responders / DVS SR DB","description":"Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase."},{"id":"OG001","title":"ESC Responders / ESC DB","description":"Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"160"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"81.8"},{"groupId":"OG001","value":"80.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR compared with ESC.","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.702","statisticalMethod":"Chi-squared","paramType":"Odds Ratio (OR)","paramValue":"1.12","ciPctValue":"95","ciLowerLimit":"0.63","ciUpperLimit":"2.00","estimateComment":"Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site."}]},{"type":"SECONDARY","title":"Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)","description":"Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if remission was achieved. 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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","populationDescription":"All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-04","paramType":"NUMBER","unitOfMeasure":"percentage of responders","timeFrame":"6 months","groups":[{"id":"OG000","title":"DVS SR Responders / DVS SR DB","description":"Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase."},{"id":"OG001","title":"ESC Responders / ESC DB","description":"Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"160"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67.9"},{"groupId":"OG001","value":"61.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR compared with ESC.","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.234","statisticalMethod":"Chi-squared","paramType":"Odds Ratio (OR)","paramValue":"1.34","ciPctValue":"95","ciLowerLimit":"0.83","ciUpperLimit":"2.16","estimateComment":"Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site."}]},{"type":"SECONDARY","title":"Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase","description":"Patients achieving a response to treatment (Responders) at the end of the 8-week acute double blind (DB) phase continued into a 6-month DB phase. Responders without remission at 8 weeks were assessed for remission status during the 6-month continuation. Remission defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale assessing 17 items characteristically associated with major depression. Individual items scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","populationDescription":"All randomized patients with baseline HAM-D17 score ≥18, who took ≥1 dose study drug, had ≥1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) but not remission (HAM-D17 score ≤ 7) at the end of the acute phase and continued treatment in the 6-month DB continuation phase.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-04","paramType":"NUMBER","unitOfMeasure":"percentage of responders","timeFrame":"6 months","groups":[{"id":"OG000","title":"DVS SR Responders / DVS SR DB","description":"Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase."},{"id":"OG001","title":"ESC Responders / ESC DB","description":"Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"55"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"88.9"},{"groupId":"OG001","value":"81.8"}]}]}]},{"type":"SECONDARY","title":"Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase","description":"Patients who didn't achieve a response to treatment at the end of the 8-week acute double blind phase entered into an OL treatment phase with DVS SR for 6 months and were evaluated to see if a response was achieved. 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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","populationDescription":"All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-04","paramType":"NUMBER","unitOfMeasure":"Percentage of Non-Responders","timeFrame":"6 months","groups":[{"id":"OG000","title":"DVS SR Non-Responders / DVS SR OL","description":"Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase."},{"id":"OG001","title":"ESC Non-Responders / DVS SR OL","description":"Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"203"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.1"},{"groupId":"OG001","value":"50.8"}]}]}]},{"type":"SECONDARY","title":"Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase","description":"Patients who did not achieve a response to treatment at the end of the 8-week acute double blind phase entered into an open label (OL) treatment phase with DVS SR for 6 months and were evaluated to see if remission was achieved. 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. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.","populationDescription":"All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-04","paramType":"NUMBER","unitOfMeasure":"Percentage of Non-Responders","timeFrame":"6 months","groups":[{"id":"OG000","title":"DVS SR Non-Responders / DVS SR OL","description":"Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase."},{"id":"OG001","title":"ESC Non-Responders / DVS SR OL","description":"Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"59"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"40.6"},{"groupId":"OG001","value":"47.5"}]}]}]},{"type":"SECONDARY","title":"Discontinuation-Emergent Signs and Symptoms (DESS) Total Score","description":"DESS is a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. 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Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days."},{"id":"OG001","title":"Escitalopram (ESC)","description":"Taper Phase Day 239 or at discontinuation: If patients taking escitalopram 20 mg/day, then decrease to 10 mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10 mg/day decreased to matching escitalopram placebo/day for 7 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"267"}]}],"classes":[{"title":"End of Therapy","categories":[{"measurements":[{"groupId":"OG000","value":"1.49","spread":"3.09"},{"groupId":"OG001","value":"1.52","spread":"3.65"}]}]},{"title":"Taper week 1","categories":[{"measurements":[{"groupId":"OG000","value":"1.18","spread":"2.12"},{"groupId":"OG001","value":"1.68","spread":"3.28"}]}]},{"title":"Taper week 2","categories":[{"measurements":[{"groupId":"OG000","value":"2.29","spread":"3.46"},{"groupId":"OG001","value":"3.16","spread":"4.58"}]}]},{"title":"Post-taper","categories":[{"measurements":[{"groupId":"OG000","value":"1.61","spread":"3.55"},{"groupId":"OG001","value":"1.48","spread":"2.86"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR vs. ESC: end of therapy","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.927","statisticalMethod":"t-test, 2 sided","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR vs. ESC: after 1 week of taper","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.055","statisticalMethod":"t-test, 2 sided","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR vs. ESC: after 2 weeks of taper","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.025","statisticalMethod":"t-test, 2 sided","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR vs. ESC: after \\> 2 weeks of taper","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.653","statisticalMethod":"t-test, 2 sided","ciPctValue":"95"}]}]},"adverseEventsModule":{"frequencyThreshold":"3","eventGroups":[{"id":"EG000","title":"Desvenlafaxine Succinate Sustained-release (DVS SR)","description":"Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved \\<50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. 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If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.","seriousNumAffected":4,"otherNumAffected":262}],"seriousEvents":[{"term":"Accidental injury","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":296},{"groupId":"EG001","numAffected":1,"numAtRisk":299}]},{"term":"Non-specific drug reaction","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":296},{"groupId":"EG001","numAffected":0,"numAtRisk":299}]},{"term":"Overdose","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":296},{"groupId":"EG001","numAffected":1,"numAtRisk":299}]},{"term":"Suicide attempt","organSystem":"General 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