Status:
TERMINATED
Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder
Lead Sponsor:
Sanofi
Conditions:
Anxiety Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 impr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00397098
Start Date
November 1 2006
End Date
September 1 2007
Last Update
March 12 2009
Active Locations (9)
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1
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
2
Sanofi-Aventis Administrative Office
Santiago, Chile
3
Sanofi-Aventis Administrative Office
Paris, France
4
Sanofi-Aventis Administrative Office
Berlin, Germany