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Efficacy and safety of Agomelatine (25 mg with potential adjustment at 50 mg) given orally once a day for 12 weeks in out-patients with Generalised Anxiety Disorder. A randomised flexible dose double-blind, placebo-controlled, parallel groups, international study.

Efficacy and safety of Agomelatine (25 mg with potential adjustment at 50 mg) given orally once a day for 12 weeks in out-patients with Generalised Anxiety Disorder. A randomised flexible dose double-blind, placebo-controlled, parallel groups, international study.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002577-23-FI
Enrollment
120
Registered
2004-11-01
Start date
2004-12-08
Completion date
Unknown
Last updated
2022-04-04

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: 3.3 Level: P.T. Classification code 10018075

Interventions

Product Code: S20098-F55 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Agomelatine CAS Number: 138112-76-2 Current Sponsor code: S20098 Concentration unit: mg milligram(s) Concentration

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient fulfilling DSM-IV-TR criteria for Generalized Anxiety Disorder with a HAM-A total score of at least 22 and a MADRS total score not more than or equal to 16 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Related to anxiety : - all types of anxiety disorders other than Generalized Anxiety Disorder such as Panic Disorder, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, Acute Stress Disorder, Agoraphobia, Social phobia, - insight-oriented and structured psychotherapy (interpersonal therapy, psychoanalysis, cognitive behavioral therapy) started within the 3 months before inclusion. Related to other psychiatric conditions : - patients meeting DSM-IV-TR current diagnosis of any Psychiatric Disorder other than GAD (within 6 months) or a previous lifetime diagnosis of Bipolar Disorder, Psychotic Disorder, - patients with a severe personality disorder other than antisocial, borderline or histrionic and prone to interfere with the evaluation of the study according to the investigator’s judgement, - patients who have a suicide risk according to the investigator's judgment or score > 2 on the MADRS item 10 or have made a suicide attempt within the last year.

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective of this study is to assess the efficacy of agomelatine compared to placebo, after a 12-week orally treatment in out-patients suffering from Generalised Anxiety Disorder (GAD) using the Hamilton Anxiety Rating Scale (HAM-A). ;Secondary Objective: The secondary objective is to provide additional safety and tolerability data on agomelatine.;Primary end point(s): Main expression of the primary efficacy criterion: - HAM-A total score expressed in terms of last post-baseline value. Secondary expression of primary efficacy criterion : - Response to treatment taking into account the last post-baseline value (defined as a decrease of at least 50% in the initial (W0) HAM-A total score).—

Countries

Finland

Outcome results

None listed

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