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

Sanofi

Status and phase

Terminated

Phase 3

Conditions

Anxiety Disorders

Treatments

Drug: SR58611A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00397098

LTE5894

EudraCT 2006-002253-71

Details and patient eligibility

About

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.

Enrollment

257 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.