Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder

Phase 3TerminatedNCT00397098

Sanofi257 enrolled

Overview

The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID) compared to placebo in the prevention of relapse of anxiety, in patients with Generalized Anxiety Disorder improved after 12 weeks of treatment with SR58611A. The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo over a 24 to 52-week treatment period. The secondary objective is to assess the safety and tolerability of SR58611A in patients with GAD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

257

Conditions

Anxiety Disorders

Interventions

SR58611ADRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: For entry into the open phase: * Patients suffering from generalized anxiety disorder, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and assessed with the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder (GAD) module. * With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) \> 20 at V1(D-4) and V2 (D-1). For entry into the double-blind randomized phase: * Improved patients with HAM-A score \< 11 at V7 (W12). Exclusion Criteria: * Inpatients. * Patients with a diagnosis of Major Depressive Disorder (DSM IV-TR) within 6 months of screening. * Patients with a MADRS total score \> 18 at screening or baseline. * Patients at immediate risk for suicidal behaviour. * Patients with other current (within 6 months) anxiety disorder according to the MINI * Patients with a lifetime history according to the MINI of: Bipolar disorder, Psychotic disorder, Antisocial personality disorder. * Patients with a current history according to the MINI of: Anorexia nervosa or bulimia nervosa in the past 6 months, Alcohol or substance dependence or abuse in the past 12 months, except nicotine or caffeine dependence. The investigator will evaluate whether there are other reasons why a patient may not participate.

Locations (9)

Sanofi-Aventis Administrative Office

Macquarie Park, Australia

Sanofi-Aventis Administrative Office

Santiago, Chile

Sanofi-Aventis Administrative Office

Paris, France

Sanofi-Aventis Administrative Office

Berlin, Germany

Outcomes

Primary Outcomes

The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by either:

HAM-A total score ≥ 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out,or

Any drop-out for lack of efficacy (according to investigator's decision),or

Prescription/use of alternative or additional treatments for relief of psychiatric symptoms.

Secondary Outcomes

Change from baseline (V7) in:-Clinical Global Impression (CGI) Severity of Illness Score

Hamilton Anxiety Rating Scale (HAM-A)

Data from ClinicalTrials.gov

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