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)

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).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38094599

Enrollment

370

Registered

2008-03-26

Start date

2007-10-15

Completion date

Unknown

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized anxiety disorder Mental and Behavioural Disorders Generalized anxiety disorder

Interventions

Agomelatine versus placebo

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Time to relapse	—

Secondary

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

Countries

Canada, Denmark, Estonia, Finland, Hungary, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026