| February 12, 2007 |
| October 9, 2009 |
| June 2007 |
| July 2009 (final data collection date for primary outcome measure) |
| The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8. [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ] |
| The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8. [ Time Frame: Week 8 ] |
| Complete list of historical versions of study NCT00435279 on ClinicalTrials.gov Archive Site |
| The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1. [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ] |
| The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1. [ Time Frame: Week 1 ] |
| |
| A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia |
| A 31-Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co-administered With Venlafaxine in Subjects With Major Depressive Disorder (MDD) and Co-existing Insomnia |
To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD). |
This is a double-blind, randomized, placebo-controlled, parallel-group study. The study consists of two groups of subjects with Major Depressive Disorder randomized to treatment with either eszopiclone 3 mg or placebo nightly at bedtime for 31 weeks beginning the night of Visit 2. In addition, all subjects will receive open-label treatment with venlafaxine. Safety and efficacy will be evaluated using clinical observations as well as physician and subject administered ratings scales. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Major Depressive Disorder
- Insomnia
|
- Drug: Eszopiclone
- Drug: Placebo
- Drug: Venlafaxine
|
| |
| |
| |
| Completed |
| 678 |
| July 2009 |
| July 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subjects must be male or female between the ages of 18 and 64, inclusive, at the time of signing consent.
- Subjects must have a primary diagnosis of Major Depressive Disorder (MDD) by DSM-IV criteria (296.XX) as determined by the Mini International Neuropsychiatric Interview (M.I.N.I.).
- MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
- Subjects must have a 17-item Hamilton Depression Scale (HAM-D-17) total score of > 22 at the screening visit.
Exclusion Criteria:
- Subjects who have a HAM-D-17 total score < 18 at Visit 2 will be discontinued from the study.
- All subjects who do not meet DSM-IV criteria (307.42) for Insomnia related to a Major Depressive Disorder.
- Subjects with less than a total sleep time < 6.5 hours at least three times per week over the past month.
|
| Both |
| 18 Years to 64 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Austria, Croatia, France, Hungary, Poland, Romania, Russian Federation, Serbia, Ukraine, United Kingdom |
| |
| NCT00435279 |
| CNS Medical Director, Sepracor Inc. |
| 190-062 |
| Sepracor, Inc. |
|
| Study Chair: |
Medical Director, CNS |
Sepracor, Inc. |
|
|
| Sepracor, Inc. |
| October 2009 |
