Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment to 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder.A 12-week randomised, double-blind, placebo-controlled, with escitalopram (10 mg/day with potential blinded adjustment to 20 mg/day) as validator, 3-arm parallel groups, international multicenter study.
- Conditions
- Generalized anxiety disorderMedDRA version: 12.0Level: LLTClassification code 10018105Term: Generalized anxiety disorder
- Registration Number
- EUCTR2009-013789-17-SK
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 390
Outpatients aged between 18 (or legal age of majority) and 65 years (inclusive), male or female, fulfilling DSM-IV-TR criteria for GAD diagnosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients suffering of all types of current anxiety disorders other than GAD within 6 months prior to selection
Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD within 6 months prior to selection
Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women
Any relevant clinical abnormality detected during physical examinations, ECG or laboratory tests likely to interfere with the study conduct or evaluations
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the superiority of agomelatine compared to placebo on anxiety in non-depressed out-patients suffering from GAD;Secondary Objective: To further describe the global clinical benefit, the effect on anxiety symptoms, sleep patterns and social functioning of agomelatine and to provide additional safety and tolerability data on agomelatine.;Primary end point(s): HAM-A total score
- Secondary Outcome Measures
Name Time Method