An Eight-Week Study Evaluating the Efficacy of Two Fixed Doses (250 mg Twice Daily and 100 mg Twice Daily) of SSR149415 in Patients With Major Depressive Disorder
NCT00361491 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 324
Last updated 2009-01-16
Summary
The purpose of the study is to evaluate the efficacy of SSR149415 in the treatment of Major Depressive Disorder, defined as a change from baseline to visit 7 in the Hamilton Depression Rating Scale.
To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate plasma concentrations of SSR149415.
Conditions
- Depressive Disorder
Interventions
- DRUG
-
SSR149415
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ICD CSD · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-08-31
- Primary Completion
- 2007-09-30
- Completion
- 2007-09-30
Countries
- Argentina
- Bulgaria
- Canada
- Chile
- Croatia
- Mexico
- Russia
Study Locations
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