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

Anxiety Disorders Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00397098
• Other study ID #: LTE5894
• Secondary ID: EudraCT 2006-002
• Status: Terminated
• Phase: Phase 3
• First received: November 7, 2006
• Last updated: March 10, 2009
• Start date: November 2006
• Est. completion date: September 2007

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilChile: Instituto de Salud Pública de ChileFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 257
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Drug:
• SR58611A

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Australia,  Chile,  France,  Germany,  Hungary,  Italy,  Mexico,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by either:
Primary	HAM-A total score = 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out,or
Primary	Any drop-out for lack of efficacy (according to investigator's decision),or
Primary	Prescription/use of alternative or additional treatments for relief of psychiatric symptoms.
Secondary	Change from baseline (V7) in:-Clinical Global Impression (CGI) Severity of Illness Score
Secondary	Hamilton Anxiety Rating Scale (HAM-A)

External Links

•   Link