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Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment at 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, with paroxetine (20 mg/day with potential progressive blinded adjustment to 40 mg/day) as validator, 3-arm parallel groups, international multicenter study.

Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment at 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, with paroxetine (20 mg/day with potential progressive blinded adjustment to 40 mg/day) as validator, 3-arm parallel groups, international multicenter study.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003421-17-CZ
Enrollment
390
Registered
2008-12-15
Start date
2009-02-16
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

Generalized Anxiety Disorder MedDRA version: 11.0 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

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

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

MeasureTime frame
Main Objective: To confirm the efficacy of agomelatine (25-50 mg/day p.o.) compared to placebo after a 12-week orally treatment in non-depressed out-patients suffering from Generalized Anxiety Disorder. ;Secondary Objective: To provide additional safety and tolerability data on agomelatine.;Primary end point(s): HAM-A—

Countries

Czech Republic, Slovakia

Outcome results

None listed

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