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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 26, 2008

Last Updated Date

March 19, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in Hamilton Depression Rating Scale total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in Hamilton Depression Rating Scale total score [ Time Frame: 8 weeks ]

Change History

Complete list of historical versions of study NCT00629551 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Change from baseline in the Changes in Sexual Functioning Questionnaire total score [ Time Frame: 8 weeks ]
Change from baseline in the Clinical Global Impression severity of illness score [ Time Frame: 8 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Depressive Disorder, Major

Intervention ^ICMJE

Drug: saredutant (SR48968)
once daily
Drug: paroxetine
once daily
Drug: placebo
once daily

Study Arm (s)

Experimental: 1
combined saredutant 100mg and paroxetine 20mg
Interventions:
- Drug: saredutant (SR48968)
- Drug: paroxetine
Experimental: 2
combined saredutant 30mg and paroxetine 20mg
Interventions:
- Drug: saredutant (SR48968)
- Drug: paroxetine
Active Comparator: 3
paroxetine 20mg

Intervention: Drug: paroxetine
Placebo Comparator: 4
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

820

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Chile, Estonia, Germany, Korea, Republic of, Mexico, Russian Federation, South Africa

Administrative Information

NCT Number ^ICMJE

NCT00629551

Other Study ID Numbers ^ICMJE

EFC10438, EudraCT 2007-003863-31

Has Data Monitoring Committee

Yes

Responsible Party

ICD Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi

Information Provided By

Sanofi

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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