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A Randomized, Double-blind, Two-arm Study Comparing the Efficacy and Safety of Trazodone Contramid® OAD and Placebo in the Treatment of Unipolar Major Depressive Disorder.
The purpose of this study was to demonstrate efficacy, safety and clinical benefit of Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder (MDD).
Details
| Lead sponsor | Labopharm Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 412 |
| Start date | 2007-06 |
| Completion | 2007-11 |
Conditions
- Major Depressive Disorder
Interventions
- Trazodone Hydrochloride (HCl) Extended-Release Tablets
- Placebo
Primary outcomes
- Change in Hamilton Depression Scale (HAMD-17) Total Score From Baseline — Baseline to Week 8
The Hamilton Depression Rating Scale 17 items \[HAMD-17\] is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill).
Countries
United States, Canada