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

NCT01606384 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-05-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)

Pharmaceutical form: Capsule Route of administration: oral

DRUG

Placebo

Pharmaceutical form: Capsule Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · 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
2006-12-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01606384 on ClinicalTrials.gov