Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415); Drug: Placebo

• Registration Number: NCT01606384
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2012-05
• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-24
• Last Update Submitted: 2012-05-24
• Study First Posted: 2012-05-25
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSR149415 - 250mg	VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)	Twice daily
Placebo	Placebo	Twice daily
SSR149415 - 100mg	VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)	Twice daily

Primary Outcome Measures

Name	Time	Method
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing	4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇺🇸 Bridgewater, New Jersey, United States