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

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: February 26, 2008
Last updated: April 26, 2016
Last verified: April 2016
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).

Condition Intervention Phase
Depressive Disorder, Major
Drug: saredutant (SR48968)
Drug: paroxetine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score [ Time Frame: 8 weeks ]
  • Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score [ Time Frame: weeks ]

Secondary Outcome Measures:
  • Change from baseline in the Clinical Global Impression severity of illness score [ Time Frame: 8 weeks ]
  • Change from baseline in the HAM-D depressed mood item scores [ Time Frame: 8 weeks ]

Enrollment: 825
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saredutant 100mg and Paroxetine 20 mg
combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks
Drug: saredutant (SR48968)
oral administration,capsules
Drug: paroxetine
oral administration, capsules
Experimental: Saredutant 30mg and Paroxetine 20mg
combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks
Drug: saredutant (SR48968)
oral administration,capsules
Drug: paroxetine
oral administration, capsules
Active Comparator: Paroxetine 20 mg and saredutant placebo
paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks
Drug: paroxetine
oral administration, capsules
Drug: placebo
oral administration, capsules
Placebo Comparator: Placebo
Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase
Drug: placebo
oral administration, capsules


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00629551

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Santiago, Chile
Sanofi-Aventis Administrative Office
Tallinn, Estonia
Sanofi-Aventis Administrative Office
Berlin, Germany
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00629551     History of Changes
Other Study ID Numbers: EFC10438
EudraCT 2007-003863-31
Study First Received: February 26, 2008
Last Updated: April 26, 2016

Keywords provided by Sanofi:
Major Depressive Disorder
Major Depressive Episode

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on May 24, 2017