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 DisorderMedDRA version: 14.1Level: PTClassification code 10018075Term: Generalised anxiety disorderSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-003699-37-SK
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 510
-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
-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
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of agomelatine compared to escitalopram after a 12-week treatment in non-depressed out-patients suffering from severe Generalized Anxiety Disorder (GAD).<br>;Secondary Objective: -to further describe the effects on anxiety symptoms, on daytime alertness, on subjective sleep, on anhedonia.<br>-to provide additional long-term efficacy data of agomelatine<br>-to provide additional safety and tolerability data on agomelatine.<br>-to evaluate the influence of genetic factors on efficacy and safety of agomelatine in a pharmacogenetic sub-study. <br>;Primary end point(s): HAM-A total score.;Timepoint(s) of evaluation of this end point: All over the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -HAM-A score <br>-CGI-S and CGI-I scores <br>-Toronto Hospital Alertness Test (THAT) total score <br>-Leeds Sleep Evaluation Questionnaire (LSEQ) scores<br>-Snaith-Hamilton Pleasure Scale (SHAPS) total score ;Timepoint(s) of evaluation of this end point: All over the study