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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
saredutant (SR48968)
paroxetine
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major Depressive Disorder, Depression, Major Depressive Episode, Antidepressant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Saredutant 100mg and Paroxetine 20 mg

Saredutant 30mg and Paroxetine 20mg

Paroxetine 20 mg and saredutant placebo

Placebo

Arm Description

combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks

combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks

paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks

Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase

Outcomes

Primary Outcome Measures

Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score
Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score

Secondary Outcome Measures

Change from baseline in the Clinical Global Impression severity of illness score
Change from baseline in the HAM-D depressed mood item scores

Full Information

First Posted
February 26, 2008
Last Updated
April 26, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00629551
Brief Title
An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder
Acronym
COMPASS
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Major Depressive Disorder, Depression, Major Depressive Episode, Antidepressant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
825 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saredutant 100mg and Paroxetine 20 mg
Arm Type
Experimental
Arm Description
combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks
Arm Title
Saredutant 30mg and Paroxetine 20mg
Arm Type
Experimental
Arm Description
combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks
Arm Title
Paroxetine 20 mg and saredutant placebo
Arm Type
Active Comparator
Arm Description
paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase
Intervention Type
Drug
Intervention Name(s)
saredutant (SR48968)
Intervention Description
oral administration,capsules
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Description
oral administration, capsules
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral administration, capsules
Primary Outcome Measure Information:
Title
Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score
Time Frame
8 weeks
Title
Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score
Time Frame
weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the Clinical Global Impression severity of illness score
Time Frame
8 weeks
Title
Change from baseline in the HAM-D depressed mood item scores
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Santiago
Country
Chile
Facility Name
Sanofi-Aventis Administrative Office
City
Tallinn
Country
Estonia
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Seoul
Country
Korea, Republic of
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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