Phase 3
N=381
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
Depression · Depressive Disorder · Depressive Disorder, Major
Bottom Line
View on ClinicalTrials.gov: NCT00369343 ↗Enrolled (actual)
381
Serious AEs
—
Results posted
May 2012
Primary outcome: Primary: Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8. — -12.64; -8.33 units on scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8. |
-12.64; -8.33 | <0.001 sig |
| SECONDARY Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score |
42.5; 22.7; 25.3; 18.6; 16.7; 17.5 | <0.001 sig |
| SECONDARY Percentage of Patients Achieving Remission |
55.6; 48.5 | — |
| SECONDARY Percentage of Patients Achieving Response to Treatment |
58.6; 31.6 | <0.001 sig |
| SECONDARY Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8 |
-8.62; -5.89 | <0.001 sig |
| SECONDARY Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8 |
0.18; 0.06 | <0.001 sig |
| SECONDARY Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months |
-12.52; -12.45 | — |
| SECONDARY Clinical Global Impression Improvement (CGI-I) Score |
1.55; 1.56 | — |
| SECONDARY Percentage of Patients Achieving Remission |
55.6; 48.5 | — |
| SECONDARY Percentage of Patients Achieving a Response to Treatment |
70.5; 66.0 | — |
| SECONDARY Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months |
-10.95; -10.38 | — |
| SECONDARY Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months |
0.19; 0.22 | — |
| SECONDARY Discontinuation-Emergent Signs and Symptoms (DESS) Total Score |
4.00; 2.07; 1.27; 2.00; 3.32; 2.47 | 0.553 |
Summary
Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.
Eligibility Criteria
Inclusion Criteria
- Peri- and 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 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 (NCT00369343). 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.