Efficacy and safety of agomelatine (25mg/day with blinded potential adjustment to 50mg/day) versus escitalopram (10mg/day with blinded potential adjustment to 20mg/day) given orally for 12 weeks in non-depressed out-patients with severe Generalized Anxiety Disorder.

• Conditions: Generalized Anxiety Disorder; MedDRA version: 17.0Level: PTClassification code 10018075Term: Generalised anxiety disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-003699-37-FI
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-29
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

-All patients selected will be aged between 18 (or legal age for majority in the country) and 65 years old inclusive, male or female, out-patients.
-fulfilling DSM-IV-TR criteria for Generalized Anxiety Disorder confirmed by the M.I.N.I. structured interview and requiring a psychotropic treatment.

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 510
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with current anxiety disorders other than Generalized Anxiety Disorder according to DSM IV criteria.
-Pregnant or breastfeeding women,
-Women of childbearing potential without effective contraception (i.e. contraceptive pill, surgical sterilization, hormonal contraceptive injections, intra-uterine contraceptive device, contraceptive implant, patch or condom). Please note that vasectomy of the partner is not considered as an effective contraception method for the patient in the framework of clinical studies,
-Patients not able to read and/or write,
-Patients who have a suicide risk according to the investigator's judgment; or with a score > 3 on the MADRS item X or who have made a suicide attempt within the past year.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified