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

Primary Purpose

Anxiety Disorders

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

SR58611A

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Anxiety disorders, Relapse prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Outcomes

Primary Outcome Measures

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

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

Hamilton Anxiety Rating Scale (HAM-A)

Full Information

NCT ID

NCT00397098

First Posted

November 7, 2006

Last Updated

March 10, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00397098

Brief Title

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

Acronym

VEGA

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Terminated

Why Stopped

reprioritization of indications

Study Start Date

November 2006 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders

Keywords

Anxiety disorders, Relapse prevention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

257 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

SR58611A

Primary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Hamilton Anxiety Rating Scale (HAM-A)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name