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Completed

NCT Number: NCT00531622

An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for 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).

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

saredutant (SR48968)

Drug

oral administration, capsules

Escitalopram

Drug

oral administration, capsules

Placebo

Drug

oral administration, capsules

Primary outcomes

  1. Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score

    Time frame: Baseline, Day 56

  2. Change from Baseline to Day 56 in the CGI-S Severity of Illness score

    Time frame: Baseline, Day 56

Secondary outcomes

  1. Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score

    Time frame: Baseline, Day 56

  2. Change from baseline to Day 56 in HAM-D depressed mood item scores.

    Time frame: Baseline, Day 56

  3. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2007
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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