| August 25, 2006 |
| October 10, 2008 |
| September 2006 |
| To demonstrate efficacy compared with placebo, measured by the change from baseline on the 17-item, Hamilton Rating Scale for Depression (HAM-D17) total score over 8 weeks of treatment with DVS SR or placebo in peri- and postmenopausal subjects with MDD. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] |
| To demonstrate efficacy compared with placebo, measured by the change from baseline on the 17-item, Hamilton Rating Scale for Depression (HAM-D17) total score over 8 weeks of treatment with DVS SR or placebo in peri- and postmenopausal subjects with MDD |
| Complete list of historical versions of study NCT00369343 on ClinicalTrials.gov Archive Site |
| To compare DVS SR to placebo with respect to remission and response rates, anxiety scores, quality of life, safety, and tolerability. [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| To compare DVS SR to placebo with respect to remission and response rates, anxiety scores, quality of life, safety, and tolerability. |
| |
| Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Vs Placebo in Peri- and Postmenopausal Women |
| A Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled Study Followed by a 6-Month Open-Label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
- Depression
- Depressive Disorder
- Depressive Disorder, Major
|
- Drug: Desvenlafaxine succinate sustained-release (DVS SR)
- Other: Placebo
|
| |
| |
| |
| Completed |
| 300 |
| July 2008 |
| November 2007 (final data collection date for primary outcome measure) |
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 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. |
| Female |
| 40 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
|
| |
| NCT00369343 |
| Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| 3151A1-403 |
| Wyeth |
|
| Study Director: |
Medical Monitor |
Wyeth |
|
|
| Wyeth |
| October 2008 |
