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 - ND

• Conditions: To evaluate the efficacy, safety and tolerability of a saredutant 100 mg dose once daily, in patients with generalized anxiety disorder; MedDRA version: 9.1Level: LLTClassification code 10002855Term: Anxiety

• Registration Number: EUCTR2006-003805-19-IT
• Lead Sponsor: sanofi-aventis recherche et de`veloppement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-16
• Last Update Posted: 19 March 2012

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 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. - To evaluate the efficacy of saredutant compared to placebo on disability and quality of life in patients with generalized anxiety disorder. - 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.