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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Pharmaceutical form: Capsule Route of administration: oral
Pharmaceutical form: Capsule Route of administration: Oral
Sanofi-Aventis
Bridgewater, New Jersey, United States
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
Time frame: 4 weeks
Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing
Time frame: 4 weeks
Number of patients with adverse events
Time frame: Up to 6 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores
Time frame: Baseline, 4 weeks
Changes Clinical Global Impression (CGI) Severity and Improvement scores
Time frame: Baseline, 4 weeks
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