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

This study has been terminated.
(reprioritization of indications)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00397098
First received: November 7, 2006
Last updated: March 10, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Anxiety Disorders
Drug: SR58611A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

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)

Enrollment: 257
Study Start Date: November 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397098

Locations
Australia
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00397098     History of Changes
Other Study ID Numbers: LTE5894, EudraCT 2006-002253-71
Study First Received: November 7, 2006
Last Updated: March 10, 2009
Health Authority: South Africa: Medicines Control Council
Chile: Instituto de Salud Pública de Chile
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Anxiety disorders, Relapse prevention

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes
Amibegron
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014