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

The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication.

Inclusion criteria

• Out-patients, 18 to 65 years of age.
• Patients suffering from 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 GAD Module.
• With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) ³ 20.
• Having given voluntarily their written informed consent to participate in the study.
• Able to comply with the protocol and follow written and verbal instructions.
• For inclusion into Segment B of the study, patients must fulfill the following criteria:
• All Segment A inclusion criteria.
• Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A.
• Not "placebo responders" (i.e., improvement £ 20 % on HAM-A total score between V1 and V2)

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