Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder (LIBRA)

Inclusion Criteria: Main inclusion criteria: Out-patients, 18 year and older. Generalized Anxiety Disorder (GAD) according toDSM-IV-TR criteria / MINI. Minimum total score of 20 on the 14-item HamiltonAnxiety Rating Scale (HAM-A) Exclusion Criteria: Main exclusion criteria: Patients with a diagnosis of Major Depressive Disorder within 6 months of study entry. Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher Patients who are assessed to have a moderate to high current risk for suicide according to the MINI, or at imminent risk for a suicide attempt Patients with other current anxiety disorder (within 6 months) 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 a current history according to the MINI of:- Anorexia nervosa or bulimia nervosa in the past 6 months,- Alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening.