Phase 3
Completed N=709
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder
Source: ClinicalTrials.gov NCT00798707 ↗Enrolled (actual)
709
Serious AEs
1.3%
Results posted
Jun 2011
Primary outcomePrimary: Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET) — -8.52; -8.98; -10.02 Units on a scale — p=0.452
Summary
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET) |
-8.52; -8.98; -10.02 | 0.452 |
| SECONDARY Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET) |
48; 57; 68; 61; 61; 62 | 0.160 |
| SECONDARY Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET) |
-1.03; -1.22; -1.24 | 0.066 |
| SECONDARY Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET) |
-9.23; -10.23; -11.29 | 0.242 |
| SECONDARY Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET) |
-4.94; -5.03; -5.65 | 0.802 |
| SECONDARY Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET) |
80; 97; 109 | 0.1099 |
| SECONDARY Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET) |
44; 40; 62 | 0.5929 |
| SECONDARY Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET) |
68; 81; 102 | 0.2232 |
| SECONDARY Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET) |
109; 118; 130 | 0.4313 |
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 judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply
Data sourced from ClinicalTrials.gov (NCT00798707). 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. Informational only — not medical advice.