Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder (LIBRA)
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 the tolerability and safety of SR58611A in patients with GAD.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||An Eight-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Escitalopram (10mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With Generalized Anxiety Disorder|
- 14-item Hamilton Anxiety Rating Scale (HAM-A) total score
- Change from baseline in Clinical Global Impression (CGI)
- Severity of Illness score
- Safety assessments
|Study Start Date:||September 2005|
|Study Completion Date:||February 2007|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
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 escitalopram (10 mg qd) as a positive control. This is an 8-week, double-blind, randomized, 3-parallel-group, placebo- and escitalopram-controlled, study.A 1-week, placebo, single-blind period precedes the 8-week randomized treatment period. A Safety Follow up Visit (Segment C) is scheduled 1 week after the acute treatmentperiod (Segment B) or early termination. This trial is designed to compare the efficacy, safety, and tolerability of SR58611A to placebo. In this study, escitalopram, a selective serotonin reuptake inhibitor (SSRI) antidepressant, is used as a positive control and has been chosen as the comparator agentas it is approved for treatment of GAD at a dose of 10 mg once daily.