Efficacy and safety of agomelatine for 12 weeks in non-depressed out-patients with Generalised Anxiety Disorder.

Conditions: Generalized anxiety disorder
MedDRA version: 13.1Level: LLTClassification code 10018105Term: Generalized anxiety disorderSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2009-013789-17-CZ

Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

Outpatients aged between 18 (or legal age of majority) and 65 years (inclusive), male or female, fulfilling DSM-IV-TR criteria for GAD diagnosis

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 350
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients suffering of all types of current anxiety disorders other than GAD within 6 months prior to selection
Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD within 6 months prior to selection
Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women
Any relevant clinical abnormality detected during physical examinations, ECG or laboratory tests likely to interfere with the study conduct or evaluations

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the superiority of agomelatine compared to placebo on anxiety in non-depressed out-patients suffering from GAD;Secondary Objective: To further describe the global clinical benefit, the effect on anxiety symptoms, sleep patterns and social functioning of agomelatine and to provide additional safety and tolerability data on agomelatine.;Primary end point(s): Hamilton Anxiety (HAM-A) total score ;Timepoint(s) of evaluation of this end point: From baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Hamilton Anxiety (HAM-A) items<br>2.Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I)<br>3.Hospital Anxiety Depression (HAD) sub-scores<br>4.Self-rating Depression Scale (SDS) scores<br>5.Leeds Sleep Evaluation Qeastionnaire (LSEQ) scores<br>6.Safety from baseline to Wend;Timepoint(s) of evaluation of this end point: 1.Hamilton anxiety (HAM-A) items: from baseline to W12<br>2.Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I): from baseline to W13<br>3.Hospital Anxiety Depression (HAD) sub-scores: from baseline to W12<br>4.Self-rating Depression Scale (SDS) scores: from baseline to W12<br>5.Leeds Sleep Evaluation Questionnaire (LSEQ) scores: from W2 to W12<br>6.Safety from baseline to Wend: final visit