Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00397098
Recruitment Status : Terminated (reprioritization of indications)
First Posted : November 8, 2006
Last Update Posted : March 12, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Drug: SR58611A Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : November 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Primary Outcome Measures :
  1. The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by either:
  2. HAM-A total score ≥ 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out,or
  3. Any drop-out for lack of efficacy (according to investigator's decision),or
  4. Prescription/use of alternative or additional treatments for relief of psychiatric symptoms.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00397098

Layout table for location information
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Sanofi-Aventis Administrative Office
Santiago, Chile
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Layout table for investigator information
Study Director: ICD CSD Sanofi

Additional Information:
Layout table for additonal information
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00397098    
Other Study ID Numbers: LTE5894
EudraCT 2006-002253-71
First Posted: November 8, 2006    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009
Keywords provided by Sanofi:
Anxiety disorders, Relapse prevention
Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Pathologic Processes
Mental Disorders
Disease Attributes
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs