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

April 25, 2016 updated by: Sanofi

An Eight-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

643

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Sanofi-Aventis Administrative Office
  • Finland
      • Helsinki, Finland
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis Administrative Office
  • Sweden
      • Bromma, Sweden
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients with recurrent Major Depressive Disorder

Exclusion Criteria:

  • Symptoms of current depressive episode for less than 30 days or more than 2 years
  • Mild depression, as measured by standard clinical research scales
  • Significant suicide risk
  • Lack of sexual activity (including masturbation)
  • Other psychiatric conditions that would obscure the results of the study
  • History of failure to respond to antidepressant treatment
  • Pregnancy or breast-feeding

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saredudant/Escitalopram
Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks
Drug: saredutant (SR48968)
oral administration, capsules
Drug: escitalopram
oral administration, capsules
Active Comparator: Placebo and Escitalopram
Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks
Drug: escitalopram
oral administration, capsules
Drug: placebo
oral administration, capsules
Placebo Comparator: Placebo
Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase
Drug: placebo
oral administration, capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score
Time Frame: Baseline, Day 56
Baseline, Day 56
Change from Baseline to Day 56 in the CGI-S Severity of Illness score
Time Frame: Baseline, Day 56
Baseline, Day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score
Time Frame: Baseline, Day 56
Baseline, Day 56
Change from baseline to Day 56 in HAM-D depressed mood item scores.
Time Frame: Baseline, Day 56
Baseline, Day 56
Percentage of patients demonstrating a treatment response
Time Frame: Day 56
response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment
Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 18, 2007

First Submitted That Met QC Criteria

September 18, 2007

First Posted (Estimate)

September 19, 2007

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC10290
  • EudraCT 2007-003159-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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