ong-term efficacy and safety of agomelatine in non-depressed out-patients with Generalized Anxiety Disorder.A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25mg/day with the possibility for blinded dose-adjustment to 50mg/day).
Phase 1
- Conditions
- MedDRA version: 10.0Level: LLTClassification code 10018075Term: <Manually entered code. Term in E.1.1>Generalised anxiety disorder
- Registration Number
- EUCTR2006-005674-47-HU
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
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 assess the efficacy of agomelatine in the prevention of relapse in non-depressed out-patients with Generalized Anxiety Disorder, during 26 weeks of study treatment after an initial response to agomelatine;Secondary Objective: To provide additional safety and tolerability data on long-term use of agomelatine and to confirm the absence of discontinuation symptoms;Primary end point(s): Time to relapse
- Secondary Outcome Measures
Name Time Method