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 patients with generalized anxiety disorder.
- Conditions
- To evaluate the efficacy, safety and tolerability of a saredutant 100 mg dose once daily, in patients with generalized anxiety disorder.
- Registration Number
- EUCTR2006-003805-19-BE
- Lead Sponsor
- sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
- Male or female patients.
- At least 18 years of age.
- Diagnosis of generalized anxiety disorder (GAD) 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) Plus Generalized Anxiety Disorder Module.
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
Minimum total score of less than 22 (<22) on the 14-item HAM-A
Total score of 18 or higher (=18) on the Montgomery-Asberg Depression Rating Scale
(MADRS)
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 patients with generalized anxiety disorder (GAD), as assessed by a change from baseline to Visit 7 (Day 56) in the 14-item HAM-A total score.;Secondary Objective: - To evaluate the tolerability and safety of saredutant in patients with generalized anxiety disorder.<br><br>- To evaluate the efficacy of saredutant compared to placebo on disability and quality of life in patients with generalized anxiety disorder.<br><br>- To evaluate plasma concentrations of saredutant and SR49596 (inactive metabolite);Primary end point(s): The change from baseline to Day 56 in the 14-item HAM-A total score in the intent-to-treat (ITT) population.
- Secondary Outcome Measures
Name Time Method