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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Major Depressive Disorder
- Sponsor
- Sanofi
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Twice daily
Intervention: Placebo
SSR149415 - 100mg
Twice daily
Intervention: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
SSR149415 - 250mg
Twice daily
Intervention: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
Outcomes
Primary Outcomes
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
Time Frame: 4 weeks
Secondary Outcomes
- Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing(4 weeks)
- Number of patients with adverse events(Up to 6 weeks)
- Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores(Baseline, 4 weeks)
- Changes Clinical Global Impression (CGI) Severity and Improvement scores(Baseline, 4 weeks)