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 (25 mg/day with the possibility for blinded dose-adjustment to 50 mg/day)

Phase 3

Completed

• Conditions: Generalized anxiety disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN38094599
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22901350

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-26
• Study Completion: 2010-03-15
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

1. Aged over 18 years
2. Out-patients of both genders
3. Fulfilling the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for GAD

Exclusion Criteria

1. Women of childbearing potential without effective contraception
2. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD
3. 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to relapse

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of anxiety (Hamilton rating scale for anxiety [HAM-A])<br>2. Safety