EUCTR2006-005674-47-EEActive, not recruitingNot Applicable
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).
Institut de Recherches Internationales Servier0 sites500 target enrollmentStarted: October 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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