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.
- Conditions
- Generalised Anxiety DisorderMedDRA version: 3.3Level: P.T.Classification code 10018075
- Registration Number
- EUCTR2004-002577-23-FI
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).<br>;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:<br>- HAM-A total score expressed in terms of last post-baseline value.<br><br>Secondary expression of primary efficacy criterion :<br>- 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).<br><br>
- Secondary Outcome Measures
Name Time Method