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An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder

NCT00531622 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2016-05-24

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).

Conditions

Interventions

DRUG

saredutant (SR48968)

oral administration, capsules

DRUG

escitalopram

oral administration, capsules

DRUG

placebo

oral administration, capsules

Sponsors & Collaborators

Principal Investigators

  • ICD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States
  • Argentina
  • Finland
  • France
  • Mexico
  • Sweden

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 NCT00531622 on ClinicalTrials.gov