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

EU CTR

Registry ID

EUCTR2006-005674-47-HU

Enrollment

500

Registered

2007-08-03

Start date

2007-10-26

Completion date

Unknown

Last updated

2021-12-21

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

Conditions

Generalised anxiety disorder MedDRA version: 10.0 Level: LLT Classification code 10018075 Term:

Interventions

Product Name: S20098 Product Code: S20098 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Agomelatine CAS Number: 138112-76-2 Current Sponsor code: S20098 Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Denmark, Estonia, Finland, Hungary, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026