Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT00863798
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 682
- Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening).
- Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20.
- Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.
- Clinical instability (25% or greater increase/decrease in HAM-D 17 total score from screening to baseline).
- Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - Desvenlafaxine succinate sustained release 50 mg Desvenlafaxine Succinate Sustained-Release 50 mg - Desvenlafaxine succinate sustained release 10 mg Desvenlafaxine Succinate Sustained-Release 10mg -
- Primary Outcome Measures
Name Time Method Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET) Baseline and Week 8 (or ET) HAM-D17: 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET) Week 8 (or ET) 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.
Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET) Baseline and Week 8 (or ET ) CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET) Baseline and Week 8 (or ET) MADRS 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).
Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET) Baseline and Week 8 (or ET ) 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. 0=none/absent and 22=most severe.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.
Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET) Week 8 (or ET) 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.
Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET) Week 8 (or ET) 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.
Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET) Week 8 (or ET) 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.
Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET) Week 8 (or ET) 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).
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Waukesha, Wisconsin, United States