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

A Double-Blind Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A Versus Placebo in the Prevention of Relapse of Anxiety up to 1 Year in Patients With GAD Improved After 12 Weeks of Open Label Treatment With SR58611A.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00397098

Acronym

VEGA

Enrollment

257

Registered

2006-11-08

Start date

2006-11-30

Completion date

2007-09-30

Last updated

2009-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Keywords

Anxiety disorders, Relapse prevention

Brief summary

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.

Interventions

DRUGSR58611A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change from baseline (V7) in:-Clinical Global Impression (CGI) Severity of Illness Score	—
Hamilton Anxiety Rating Scale (HAM-A)	—

Countries

Australia, Chile, France, Germany, Hungary, Italy, Mexico, Russia, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026