Phase 3
N=682
Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00863798 ↗Enrolled (actual)
682
Serious AEs
0.7%
Results posted
May 2011
Primary outcome: Primary: Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET) — -8.42; -9.28; -8.92 Units on a scale — p=0.175
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Desvenlafaxine Succinate Sustained-Release 10mg (Drug); Desvenlafaxine Succinate Sustained-Release 50 mg (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET) |
-8.42; -9.28; -8.92 | 0.175 |
| SECONDARY Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET) |
49; 50; 55; 54; 75; 53 | 0.076 |
| SECONDARY Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET) |
-1.08; -1.23; -1.11 | 0.130 |
| SECONDARY Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET) |
-9.87; -11.28; -10.76 | 0.114 |
| SECONDARY Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET) |
-4.75; -5.49; -5.19 | 0.054 |
| SECONDARY Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET) |
85; 100; 91 | 0.2415 |
| SECONDARY Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET) |
42; 52; 39 | 0.3667 |
| SECONDARY Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET) |
84; 95; 90 | 0.3893 |
| SECONDARY Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET) |
103; 125; 108 | 0.0536 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00863798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.