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Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

NCT00252356 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2009-03-12

No results posted yet for this study

Summary

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. The study is a multicenter, US and Canadian, randomized, double-blind, 3-parallel-group, placebo- and escitalopram-controlled, Phase III study consisting of four segments (A, B, C and D). Segment A is a 1-week, placebo, single-blind period. Segment B is an 8-week, double-blind period. Segment C is an optional 18-week double-blind extension period. Segment D is a 1-week safety follow-up period after study drug discontinuation or early termination (during Segment B or C).

Conditions

Interventions

DRUG

SR58611A

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-01-31
Completion
2007-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT00252356 on ClinicalTrials.gov