Status:
COMPLETED
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder
Lead Sponsor:
Sanofi
Conditions:
Anxiety Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 350 mg and 700 mg dose...
Eligibility Criteria
Inclusion
- Patients suffering from generalized anxiety disorder (GAD) as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module
- Total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) equal or above 20.
Exclusion
- Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within 6 months of study entry.
- Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher at screening or baseline visits.
- Patients having a moderate to high current risk for suicide.
- Patients with other current anxiety disorder assessed with the MINI: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder.
- Patients with a lifetime history according to the MINI of: bipolar disorders, psychotic disorders, antisocial personality disorder.
- Patients with severe or unstable concomitant medical conditions according to the Investigator's judgment.
- Females who are pregnant or lactating.
- Female patients of childbearing potential must use an effective method of birth control during the entire study period.
- Patients with positive test for any illicit drug included in the urine drug screen.
- Participation in a clinical trial of an experimental therapy within 3 months prior to screening
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT00332891
Start Date
March 1 2006
End Date
April 1 2007
Last Update
March 9 2009
Active Locations (5)
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1
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
2
Sanofi-Aventis Administrative Office
Zagreb, Croatia
3
Sanofi-Aventis Administrative Office
Prague, Czechia
4
Sanofi-Aventis Administrative Office
Warsaw, Poland