Long-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)

• Register: ISRCTN
• Last refreshed on: 21 May 2018
• Main ID: ISRCTN38094599
• Date of registration: 26/03/2008
• Prospective Registration: No
• Primary sponsor: Institut de Recherches Internationales Servier (France)
• Public title: Long-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)
• Scientific title: Long-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).
• Date of first enrolment: 15/10/2007
• Target sample size: 370
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN38094599
• Study type: Interventional
• Study design: Randomised double-blind parallel-group placebo-controlled multi-centre phase III study (Treatment)
• Phase: Phase III

Countries of recruitment

Canada, Denmark, Estonia, Finland, Hungary, Sweden

Contacts

• Name: Istvan Bitter

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Generalized anxiety disorder
Mental and Behavioural Disorders
Generalized anxiety disorder

Intervention(s)

Agomelatine versus placebo

Primary Outcome(s)

Time to relapse

Secondary Outcome(s)

1. Evaluation of anxiety (Hamilton rating scale for anxiety [HAM-A])
2. Safety

Secondary ID(s)

2006-005674-47

CL3-20098-050

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Ethics review

Status:
Approval date:
Contact:

First ethics committee approval in Estonia (Tallin Medical Research Ethics Committee) on 16/08/2007 (ref: 1121)

Results

• Results available: Yes
• Date Completed: 15/03/2010