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

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

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).

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: placebo; Drug: saredutant (SR48968); Drug: paroxetine

• Study Type: Interventional
• Enrollment (Actual): 825
• Phase: Phase 3

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Sanofi-Aventis Administrative Office
• Estonia
  • Tallinn, Estonia
    • Sanofi-Aventis Administrative Office
• Germany
  • Berlin, Germany
    • Sanofi-Aventis Administrative Office
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Sanofi-Aventis Administrative Office
• Mexico
  • Mexico, Mexico
    • Sanofi-Aventis Administrative Office
• Russian Federation
  • Moscow, Russian Federation
    • Sanofi-Aventis Administrative Office
• South Africa
  • Midrand, South Africa
    • Sanofi-Aventis Administrative Office
• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi-Aventis Administrative Office

Participation Criteria

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: placebo; oral administration, capsules; Drug: paroxetine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score	8 weeks
Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score	weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the Clinical Global Impression severity of illness score	8 weeks
Change from baseline in the HAM-D depressed mood item scores	8 weeks

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: February 26, 2008
• First Submitted That Met QC Criteria: March 5, 2008
• First Posted (Estimate): March 6, 2008

Study Record Updates

• Last Update Posted (Estimate): May 26, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Depression; Major Depressive Disorder; Antidepressant; Major Depressive Episode
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: EFC10438; EudraCT 2007-003863-31