Major Depressive Disorder Clinical Trial
Official title:
A Double-blind, Placebo-controlled Study Evaluating the Pharmacodynamic Effects of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) on Hypothalamic-pituitary-adrenal Axis Function in Outpatients With Major Depressive Disorder
Primary Objective:
- To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on
hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.
Secondary Objectives:
- To evaluate the tolerability and safety of SSR149415 in patients with major depressive
disorder.
- To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in
patients with major depressive disorder.
- To evaluate plasma concentrations of SSR149415.
The study consisted of three segments (A, B and C). Segment A was a 1 to 4-week, drug-free,
screening and baseline period. Segment B was a 4-week, double-blind period. After the last
dose of double-blind study medication in Segment B, all patients had to enter Segment C, a
1-week drug-free, follow-up period.
The total study duration for one patient participating in all segments of the study was 6
weeks.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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