Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment at 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, with paroxetine (20 mg/day with potential progressive blinded adjustment to 40 mg/day) as validator, 3-arm parallel groups, international multicenter study.
Phase 1
- Conditions
- Generalized Anxiety DisorderMedDRA version: 11.0 Level: LLT Classification code 10018075 Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2008-003421-17-CZ
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Out-patients of both genders, - Aged over 18 years, - Fulfilling DSM-IV-TR criteria for Generalized Anxiety Disorder.
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Women of childbearing potential without effective contraception, - Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD, - Any clinically relevant abnormality detected during the physical examination, 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 efficacy of agomelatine (25-50 mg/day p.o.) compared to placebo after a 12-week orally treatment in non-depressed out-patients suffering from Generalized Anxiety Disorder. ;Secondary Objective: To provide additional safety and tolerability data on agomelatine.;Primary end point(s): HAM-A
- Secondary Outcome Measures
Name Time Method