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The study will also assess changes in sexual function and general and functional quality of life outcomes."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":709,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Desvenlafaxine succinate sustained-release 25 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)"]},{"label":"Desvenlafaxine succinate sustained-release 50 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"25 mg tablet, once daily dosing for 8 weeks","armGroupLabels":["Desvenlafaxine succinate sustained-release 25 mg"]},{"type":"DRUG","name":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"50 mg tablet, once daily dosing for 8 weeks","armGroupLabels":["Desvenlafaxine succinate sustained-release 50 mg"]},{"type":"DRUG","name":"placebo","description":"Matching placebo tablets (25 or 50 mg). 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HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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.","timeFrame":"Week 8 (or ET)"},{"measure":"Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)","description":"Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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.","timeFrame":"Week 8 (or ET)"},{"measure":"Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)","description":"A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).","timeFrame":"Week 8 (or ET)"},{"measure":"Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)","description":"CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.","timeFrame":"Week 8 (or ET)"}],"otherOutcomes":[{"measure":"Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations","description":"Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.","timeFrame":"Week 2, 4 and 8 (or ET)"},{"measure":"Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)","description":"SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.","timeFrame":"Baseline and Week 8 (or ET)"},{"measure":"Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)","description":"WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).","timeFrame":"Baseline and Week 8 (or ET)"},{"measure":"Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)","description":"ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. 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Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435."},{"pmid":"29140227","type":"DERIVED","citation":"Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15."},{"pmid":"26709542","type":"DERIVED","citation":"McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13."},{"pmid":"26644956","type":"DERIVED","citation":"McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015."},{"pmid":"25758058","type":"DERIVED","citation":"Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26."},{"pmid":"23334675","type":"DERIVED","citation":"Iwata N, Tourian KA, Hwang E, Mele L, Vialet C. Efficacy and safety of desvenlafaxine 25 and 5050% shaded blockmg/day in a randomized, placebo-controlled study of depressed outpatients. J Psychiatr Pract. 2013 Jan;19(1):5-14. doi: 10.1097/01.pra.0000426323.59698.64."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3359&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained%20Release%20%28DVS%20SR%29%20in%20the%20Treatment%20of%20Major%20Depressive%20Disorder"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 907 potential participants were screened for this study. 813 participants were enrolled and received single-blind placebo during the screening period prior to randomization.","groups":[{"id":"FG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"FG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"FG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"235"},{"groupId":"FG001","numSubjects":"237"},{"groupId":"FG002","numSubjects":"237"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"231"},{"groupId":"FG001","numSubjects":"232"},{"groupId":"FG002","numSubjects":"236"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"209"},{"groupId":"FG001","numSubjects":"204"},{"groupId":"FG002","numSubjects":"215"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"22"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"8"}]},{"type":"Failed to return","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Investigator","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Randomized not treated","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"BG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"BG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"231"},{"groupId":"BG001","value":"232"},{"groupId":"BG002","value":"236"},{"groupId":"BG003","value":"699"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"40.26","spread":"12.32"},{"groupId":"BG001","value":"40.19","spread":"11.88"},{"groupId":"BG002","value":"38.59","spread":"12.08"},{"groupId":"BG003","value":"39.67","spread":"12.10"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"128"},{"groupId":"BG001","value":"127"},{"groupId":"BG002","value":"131"},{"groupId":"BG003","value":"386"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"103"},{"groupId":"BG001","value":"105"},{"groupId":"BG002","value":"105"},{"groupId":"BG003","value":"313"}]}]}]},{"title":"Hamilton Psychiatric Scale for Depression-17 item (HAM-D17) total score","description":"HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. 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Item 13 is scored 0-2 and all others are scored 0-4.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12.58","spread":"1.79"},{"groupId":"BG001","value":"12.61","spread":"1.77"},{"groupId":"BG002","value":"12.43","spread":"1.75"},{"groupId":"BG003","value":"12.54","spread":"1.77"}]}]}]},{"title":"Sheehan Disability Scale (SDS) Total Score","description":"SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities.Participant rates extent to which each of these domains are impaired by his/her symptoms using 10 point visual analog scale:(0=not at all impaired,10=extremely impaired) for total maximum score of 30.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16.31","spread":"7.78"},{"groupId":"BG001","value":"17.02","spread":"7.34"},{"groupId":"BG002","value":"16.39","spread":"7.27"},{"groupId":"BG003","value":"16.57","spread":"7.46"}]}]}]},{"title":"World Health Organization 5-Item Well-Being Index (WHO-5)","description":"WHO-5 evaluates positive psychological well-being. 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Sexual dysfunction=ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"66.4"},{"groupId":"BG001","value":"66.1"},{"groupId":"BG002","value":"62.3"},{"groupId":"BG003","value":"194.8"}]}]}]},{"title":"Participants with Columbia Suicide-Severity Rating Scale (C-SSRS) total score","description":"C-SSRS was mapped into Columbia Classification Algorithm of Suicide Assessment (C-CASA)(1-4) to prospectively assess whether participants experienced: completed suicide(1),suicide attempt(2),preparatory acts toward imminent suicidal behavior(3),suicidal ideation,any suicidal behavior and ideation(4).Participants with \"yes\" response were reported.","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Completed Suicide","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]},{"title":"Suicide attempt","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]},{"title":"Preparatory acts toward imminent suicidal behavior","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]},{"title":"Suicidal ideation","categories":[{"measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"113"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)","description":"HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. 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If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"232"},{"groupId":"OG002","value":"236"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.03","spread":"0.07"},{"groupId":"OG001","value":"-1.22","spread":"0.07"},{"groupId":"OG002","value":"-1.24","spread":"0.07"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.066","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.01","ciUpperLimit":"0.39"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.038","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.01","ciUpperLimit":"0.41"}]},{"type":"SECONDARY","title":"Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)","description":"MADRS measures the overall severity of depressive symptoms. 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If participant had a missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"231"},{"groupId":"OG002","value":"235"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.23","spread":"0.61"},{"groupId":"OG001","value":"-10.23","spread":"0.60"},{"groupId":"OG002","value":"-11.29","spread":"0.60"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.242","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"1.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.68","ciUpperLimit":"2.68"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.016","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"2.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.39","ciUpperLimit":"3.73"}]},{"type":"SECONDARY","title":"Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)","description":"HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.","populationDescription":"ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit,LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"232"},{"groupId":"OG002","value":"236"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.94","spread":"0.26"},{"groupId":"OG001","value":"-5.03","spread":"0.26"},{"groupId":"OG002","value":"-5.65","spread":"0.25"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.802","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.62","ciUpperLimit":"0.80"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.048","statisticalMethod":"ANCOVA","paramType":"Median Difference (Final Values)","paramValue":"0.72","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.01","ciUpperLimit":"1.43"}]},{"type":"SECONDARY","title":"Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)","description":"A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in 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 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.","populationDescription":"ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"232"},{"groupId":"OG002","value":"236"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"97"},{"groupId":"OG002","value":"109"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1099","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.363","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.93","ciUpperLimit":"1.99"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0154","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.591","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.09","ciUpperLimit":"2.32"}]},{"type":"SECONDARY","title":"Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)","description":"Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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.","populationDescription":"ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"232"},{"groupId":"OG002","value":"236"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"62"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5929","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"0.878","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.54","ciUpperLimit":"1.41"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0852","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.474","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.95","ciUpperLimit":"2.29"}]},{"type":"SECONDARY","title":"Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)","description":"A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).","populationDescription":"ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"231"},{"groupId":"OG002","value":"235"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"81"},{"groupId":"OG002","value":"102"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2232","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.277","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.86","ciUpperLimit":"1.89"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0022","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.827","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.24","ciUpperLimit":"2.69"}]},{"type":"SECONDARY","title":"Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)","description":"CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.","populationDescription":"ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"232"},{"groupId":"OG002","value":"236"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"118"},{"groupId":"OG002","value":"130"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted with a logistic regression model with treatment as a factor.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4313","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.158","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.80","ciUpperLimit":"1.67"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted with a logistic regression model with treatment as a factor.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0888","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.372","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.95","ciUpperLimit":"1.97"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations","description":"Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.","populationDescription":"PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanogram(ng)/mL","timeFrame":"Week 2, 4 and 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)","description":"SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.","populationDescription":"ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"232"},{"groupId":"OG002","value":"236"}]}],"classes":[{"title":"Total Score (n=227,224,235)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.17","spread":"0.43"},{"groupId":"OG001","value":"-3.26","spread":"0.43"},{"groupId":"OG002","value":"-3.23","spread":"0.42"}]}]},{"title":"Work/Studies Component (n=227,225,235)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.77","spread":"0.16"},{"groupId":"OG001","value":"-1.07","spread":"0.15"},{"groupId":"OG002","value":"-1.12","spread":"0.15"}]}]},{"title":"Social Life Component (n=229,231,235)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.86","spread":"0.16"},{"groupId":"OG001","value":"-1.26","spread":"0.15"},{"groupId":"OG002","value":"-1.21","spread":"0.15"}]}]},{"title":"Family Life/Home Responsibilities (n=14,2,13)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.54","spread":"0.88"},{"groupId":"OG001","value":"-1.83","spread":"2.12"},{"groupId":"OG002","value":"-0.97","spread":"0.89"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.073","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"1.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.10","ciUpperLimit":"2.29"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.078","statisticalMethod":"ANCOVA","paramType":"Median Difference (Final Values)","paramValue":"1.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.12","ciUpperLimit":"2.24"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.176","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"0.73"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.109","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.08","ciUpperLimit":"0.77"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.064","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.41","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.02","ciUpperLimit":"0.84"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.104","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.07","ciUpperLimit":"0.78"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.538","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"1.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.98","ciUpperLimit":"5.57"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.689","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.43","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.76","ciUpperLimit":"2.62"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)","description":"WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).","populationDescription":"ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline and Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"231"},{"groupId":"OG002","value":"235"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.62","spread":"0.31"},{"groupId":"OG001","value":"3.43","spread":"0.31"},{"groupId":"OG002","value":"3.25","spread":"0.31"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.066","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-0.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.67","ciUpperLimit":"0.05"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.150","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-0.63","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.48","ciUpperLimit":"0.23"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)","description":"ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week should be instructed to not complete questions 3 through 5.","populationDescription":"The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"112"},{"groupId":"OG002","value":"113"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"55.0"},{"groupId":"OG001","value":"52.7"},{"groupId":"OG002","value":"55.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.8758","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"0.951","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.51","ciUpperLimit":"1.78"},{"groupIds":["OG000","OG002"],"groupDescription":"Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6397","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.165","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.61","ciUpperLimit":"2.21"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)","description":"C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of \"Yes\" on \"Actual Attempt\"),preparatory acts toward imminent suicidal behavior (3)(\"Yes\" on \"Preparatory Acts or Behavior\"),suicidal ideation (4)(\"Yes\" on \"Wish to be dead\",\"Non-Specific Active Suicidal Thoughts\",\"Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(\"Yes\" on \"Has subject engaged in Non-suicidal Self-Injurious Behavior\").","populationDescription":"The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 8 (or ET)","groups":[{"id":"OG000","title":"Placebo","description":"Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) ."},{"id":"OG001","title":"DVS SR 25 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET."},{"id":"OG002","title":"DVS SR 50 mg","description":"DVS SR 50 mg daily until Day 56 (Week 8) or ET."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"232"},{"groupId":"OG002","value":"236"}]}],"classes":[{"title":"Completed suicide","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Suicide attempt","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Preparatory acts toward imminent suicidal behavior","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Suicidal ideation","categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"50"},{"groupId":"OG002","value":"47"}]}]},{"title":"Any suicidal behavior and/or ideation","categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"50"},{"groupId":"OG002","value":"47"}]}]},{"title":"Self-injurious behavior, no suicidal intent","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","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. 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