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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00397098
• Date of registration: 07/11/2006
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder VEGA
• Scientific 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.
• Date of first enrolment: November 2006
• Target sample size: 257
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00397098
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: ICD CSD
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anxiety Disorders

Intervention(s)

Drug: SR58611A

Primary Outcome(s)

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(s)

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

Hamilton Anxiety Rating Scale (HAM-A)

Secondary ID(s)

LTE5894

EudraCT 2006-002253-71

Source(s) of Monetary Support

Please refer to primary and secondary sponsors