An Eight-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study toEvaluate the Efficacy and Safety of Fixed Dose of SR58611A 350 mg Twice a Day inElderly Patients with Generalized Anxiety Disorder with an Optional Twenty-Fourweek Extension - GEMINI

• Conditions: Generalized Anxiety Disorder

• Registration Number: EUCTR2006-004147-33-AT
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Patients diagnosed with Generalized Anxiety Disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria diagnosed by a psychiatrist and supported 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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients < 60 years of age
• 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)
• MMSE score of 22 or less (=22)
• See protocol for a complete list of Exclusion Criteria

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by a change from baseline to Visit 7 (Day 56) in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.;Primary end point(s): The primary efficacy criterion is the change from baseline in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.;Secondary Objective: • To evaluate the tolerability and safety of SR58611A in elderly patients with generalized anxiety disorder<br>• To evaluate the efficacy of SR58611A compared to placebo on disability and quality of life in elderly patients with generalized anxiety disorder<br>• To evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with generalized anxiety disorder