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Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder

NCT00432614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2009-03-25

No results posted yet for this study

Summary

The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.

The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.

Conditions

Interventions

DRUG

SR58611A

oral administration

DRUG

escitalopram

oral administration

DRUG

placebo

oral administration

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Belgium
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • India
  • Malaysia
  • Morocco
  • South Korea
  • Taiwan
  • Tunisia
  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT00432614 on ClinicalTrials.gov