An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder

Phase 3

Completed

• Conditions: Anxiety Disorders

• Registration Number: NCT00332891
• Lead Sponsor: Sanofi

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 350 mg and 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD). The secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-06
• Last Update Posted: 2009-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 508

Inclusion Criteria

• Patients suffering from generalized anxiety disorder (GAD) as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module
• Total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) equal or above 20.

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Exclusion Criteria

• Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within 6 months of study entry.
• Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher at screening or baseline visits.
• Patients having a moderate to high current risk for suicide.
• Patients with other current anxiety disorder assessed with the MINI: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder.
• Patients with a lifetime history according to the MINI of: bipolar disorders, psychotic disorders, antisocial personality disorder.
• Patients with severe or unstable concomitant medical conditions according to the Investigator's judgment.
• Females who are pregnant or lactating.
• Female patients of childbearing potential must use an effective method of birth control during the entire study period.
• Patients with positive test for any illicit drug included in the urine drug screen.
• Participation in a clinical trial of an experimental therapy within 3 months prior to screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.

Secondary Outcome Measures

Name	Time	Method
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the CGI Severity of Illness Score, percentage of patients with HAM-A treatment response and change from baseline in the HAM-A somatic and psychic anxiety factor scores.

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇷🇸 Belgrade, Serbia