Skip to main content
OpenTrials
Completed

NCT Number: NCT00629551

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Disorder, Major Behavior Behavioral Symptoms Depression Depressive Disorder 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, Santiago, Chile

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

Treatment and study plan

saredutant (SR48968)

Drug

oral administration,capsules

paroxetine

Drug

oral administration, capsules

Placebo

Drug

oral administration, capsules

Primary outcomes

  1. Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score

    Time frame: 8 weeks

  2. Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score

    Time frame: weeks

Secondary outcomes

  1. Change from baseline in the Clinical Global Impression severity of illness score

    Time frame: 8 weeks

  2. Change from baseline in the HAM-D depressed mood item scores

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

An Eight-week, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Saredutant (100 mg and 30 mg) Once Daily in Combination With Paroxetine 20 mg Once Daily Compared to Saredutant Placebo in Combination With Paroxetine 20 mg Once Daily in Patients With Major Depressive Disorder

Acronym: COMPASS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2008
Registry last updated
May 26, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.