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.

Institut de Recherches Internationales Servier0 个研究点目标入组 120 人开始时间: 2004年11月1日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•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.

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