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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00629551
First received: February 26, 2008
Last updated: March 19, 2009
Last verified: March 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Hamilton Depression Rating Scale total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the Changes in Sexual Functioning Questionnaire total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Clinical Global Impression severity of illness score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 820
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: 1
combined saredutant 100mg and paroxetine 20mg
Drug: saredutant (SR48968)
once daily
Drug: paroxetine
once daily
Experimental: 2
combined saredutant 30mg and paroxetine 20mg
Drug: saredutant (SR48968)
once daily
Drug: paroxetine
once daily
Active Comparator: 3
paroxetine 20mg
Drug: paroxetine
once daily
Placebo Comparator: 4 Drug: placebo
once daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00629551

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Estonia
Sanofi-Aventis Administrative Office
Tallinn, Estonia
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Mexico
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
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00629551     History of Changes
Other Study ID Numbers: EFC10438, EudraCT 2007-003863-31
Study First Received: February 26, 2008
Last Updated: March 19, 2009
Health Authority: United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
Russia: Ministry of Health of the Russian Federation

Keywords provided by Sanofi:
Major Depressive Disorder
Depression
Major Depressive Episode
Antidepressant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014