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 - COMPASS

• Conditions: Major Depressive Disorder; MedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOS

• Registration Number: EUCTR2007-003863-31-EE
• Lead Sponsor: Sanofi-Aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 820

Inclusion Criteria

- Male or female outpatients
- 18 to 65 years of age
- Diagnosis of major depressive disorder, recurrent episode, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria, recurrent episode, and confirmed by the Mini International Neuropsychiatric Interview (MINI) criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Montgomery-Asberg Depression Rating Scale (MADRS) total score <24
- 17-item HAM-D total score of <18

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified