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

Depressive Disorder, Major Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629551
• Other study ID #: EFC10438
• Secondary ID: EudraCT 2007-003
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2008
• Last updated: March 19, 2009
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChile: Instituto de Salud Pública de ChileRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Hamilton Depression Rating Scale total score		8 weeks	No
Secondary	Change from baseline in the Changes in Sexual Functioning Questionnaire total score		8 weeks	No
Secondary	Change from baseline in the Clinical Global Impression severity of illness score		8 weeks	No