| November 29, 2006 |
| November 3, 2008 |
| December 2006 |
| February 2008 (final data collection date for primary outcome measure) |
| To assess efficacy measured by the change from baseline on the Hamilton Rating Scale for Depression total score over 8 weeks of treatment with DVS SR compared to treatment with escitalopram in postmenopausal women with MDD. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] |
| To assess efficacy measured by the change from baseline on the Hamilton Rating Scale for Depression total score over 8 weeks of treatment with DVS SR compared to treatment with escitalopram in postmenopausal women with MDD. |
| Complete list of historical versions of study NCT00406640 on ClinicalTrials.gov Archive Site |
| To compare DVS SR to escitalopram 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 escitalopram with respect to remission and response rates, anxiety scores, quality of life, safety, and tolerability. |
| |
| Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women |
| A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depressive Disorder |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study |
- Depression
- Depressive Disorder
- Depressive Disorder, Major
|
- Drug: Desvenlafaxine succinate sustained-release (DVS SR)
- Drug: Escitalopram
|
| |
| |
| |
| Completed |
| 500 |
| October 2008 |
| February 2008 (final data collection date for primary outcome measure) |
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. |
| Female |
| 40 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Argentina, Chile, Colombia, Mexico, Peru |
| |
| NCT00406640 |
| Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| 3151A1-402 |
| Wyeth |
|
| Study Director: |
Medical Monitor |
Wyeth |
|
| Principal Investigator: |
Trial Manager |
For Argentina: Scheima@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For Chile: scheima@wyeth.com |
|
| Principal Investigator: |
Trial Manager |
For Mexico: gomezzlj@wyeth.com |
|
|
| Wyeth |
| November 2008 |
