An Eight-Week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, with Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients with Major Depressive Disorder
- Conditions
- to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients with Major Depressive Disorder (MDD)
- Registration Number
- EUCTR2006-003793-94-CZ
- Lead Sponsor
- sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 375
Inclusion Criteria
- Male or female
- At least 60 years of age
- Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria and confirmed by the 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) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Total score of 22 or less on the Montgomery-Asberg Depression Rating Scale (MADRS)
- HAM-D total score of 16 or less
- MMSE score of 22 or less
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of saredutant 100 mg once daily compared to placebo with escitalopram as an active control, in elderly patients with major depressive disorder (MDD), as assessed by a change from baseline to Visit 6 (Day 56) in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.;Secondary Objective: - To evaluate the tolerability and safety of saredutant in elderly patients with major depressive disorder<br>- To evaluate the efficacy of saredutant compared to placebo on disability and quality of life in patients with major depressive disorder<br>- To evaluate plasma concentrations of saredutant and SR49596 (inactive metabolite)<br>- To evaluate the safety and tolerability of twenty-four weeks of additional treatment with saredutant in patients completing the initial eight-week treatment period;Primary end point(s): change from baseline to Visit 6 (Day 56) in the 17-item HAM-D total score in the intent-to-treat (ITT) population
- Secondary Outcome Measures
Name Time Method