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

March 10, 2009 updated by: Sanofi

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.

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 Overview

Status

Terminated

Conditions

Anxiety Disorders

Intervention / Treatment

Drug: SR58611A

Study Type

Interventional

Enrollment (Actual)

257

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Macquarie Park, Australia
    - Sanofi-Aventis Administrative Office
Chile
- - Santiago, Chile
    - Sanofi-Aventis Administrative Office
France
- - Paris, France
    - Sanofi-Aventis Administrative Office
Germany
- - Berlin, Germany
    - Sanofi-Aventis Administrative Office
Hungary
- - Budapest, Hungary
    - Sanofi-Aventis Administrative Office
Italy
- - Milan, Italy
    - Sanofi-Aventis Administrative Office
Mexico
- - Mexico, Mexico
    - Sanofi-Aventis Administrative Office
Russian Federation
- - Moscow, Russian Federation
    - Sanofi-Aventis Administrative Office
Spain
- - Barcelona, Spain
    - Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

November 7, 2006

First Submitted That Met QC Criteria

November 7, 2006

First Posted (Estimate)

November 8, 2006

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 10, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Anxiety disorders, Relapse prevention

Additional Relevant MeSH Terms

Other Study ID Numbers

LTE5894
EudraCT 2006-002253-71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.