An eight-week, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily in patients with major depressive disorder

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

• Registration Number: EUCTR2007-003159-36-FI
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

1. Male or female patients.
2. 18 to 65 years of age.
3. Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).

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 of less than 24 (<24) at Visit 1 (Day –7) or Visit 2 (Day –1).
- 17-item HAM-D total score of less than 18 (<18) at Visit 1 (Day –7) or Visit 2 (Day –1)

Study & Design

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