Status:
COMPLETED
Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder
Lead Sponsor:
Sanofi
Conditions:
Anxiety Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of a fixed dose of SR58611A (350mg q12) compared to placebo in patients with GeneralizedAnxiety Disorder (GAD) using escitalopram (10 mg qd) as positive control. To evaluate t...
Detailed Description
The current study will be conducted to evaluate the efficacy, safety, and tolerability of SR58611A (350 mg q12) compared to placebo in patients with generalized anxiety disorder (GAD), using escitalop...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Out-patients, 18 year and older.
- Generalized Anxiety Disorder (GAD) according toDSM-IV-TR criteria / MINI.
- Minimum total score of 20 on the 14-item HamiltonAnxiety Rating Scale (HAM-A)
Exclusion
- Main exclusion criteria:
- Patients with a diagnosis of Major Depressive Disorder within 6 months of study entry.
- Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher
- Patients who are assessed to have a moderate to high current risk for suicide according to the MINI, or at imminent risk for a suicide attempt
- Patients with other current anxiety disorder (within 6 months) 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 a current history according to the MINI of:- Anorexia nervosa or bulimia nervosa in the past 6 months,- Alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
- Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
- Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00252343
Start Date
September 1 2005
End Date
February 1 2007
Last Update
March 12 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807