Phase 3
N=595
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women
Depression · Depressive Disorder · Depressive Disorder, Major
Bottom Line
View on ClinicalTrials.gov: NCT00406640 ↗Enrolled (actual)
595
Serious AEs
—
Results posted
Jun 2010
Primary outcome: Primary: Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8 — -13.63; -14.30 units on scale — p=0.243
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Desvenlafaxine succinate sustained-release (DVS SR) (Drug); Escitalopram (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8 |
-13.63; -14.30 | 0.243 |
| SECONDARY Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase) |
64.3; 73.4 | 0.077 |
| SECONDARY Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase) |
37.9; 48.1 | 0.0054 sig |
| SECONDARY Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks |
1.93; 1.81 | 0.260 |
| SECONDARY Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week |
-2.09; -2.22 | 0.239 |
| SECONDARY Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score |
-11.37; -11.73 | 0.516 |
| SECONDARY Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8 |
0.25; 0.24 | 0.635 |
| SECONDARY Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase) |
81.8; 80.0 | 0.702 |
| SECONDARY Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase) |
67.9; 61.3 | 0.234 |
| SECONDARY Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase |
88.9; 81.8 | — |
| SECONDARY Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase |
39.1; 50.8 | — |
| SECONDARY Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase |
40.6; 47.5 | — |
| SECONDARY Discontinuation-Emergent Signs and Symptoms (DESS) Total Score |
1.49; 1.52; 1.18; 1.68; 2.29; 3.16 | 0.927 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women between the ages of 40 and 70 years, inclusive.
- A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified MINI International Neuropsychiatric Interview (MINI).
- Montgomery-Asberg Depression Rating Scale (MADRS) total score > or = 22 at the screening and baseline visit.
Exclusion Criteria
- Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
- 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.
- A history or active presence of clinically important medical disease.
Additional criteria apply.
Data sourced from ClinicalTrials.gov (NCT00406640). 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.