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

NCT00629551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 825

Last updated 2016-05-26

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

saredutant (SR48968)

oral administration,capsules

DRUG

paroxetine

oral administration, capsules

DRUG

placebo

oral administration, capsules

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · 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
2008-02-29
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States
  • Chile
  • Estonia
  • Germany
  • Mexico
  • Russia
  • South Africa
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
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 NCT00629551 on ClinicalTrials.gov