Efficacy and safety of agomelatine for 12 weeks in non-depressed out-patients with Generalised Anxiety Disorder
Phase 3
Completed
- Conditions
- Generalised Anxiety DisorderMental and Behavioural DisordersOther anxiety disorders
- Registration Number
- ISRCTN03554974
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24569045
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 390
Inclusion Criteria
1. Out-patients of both genders aged between 18 (or legal majority) and 65 years of age (inclusive)
2. Fulfilling American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria for GAD
Exclusion Criteria
1. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD within 6 months prior to selection
2. Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women
3. 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hamilton Anxiety (HAM-A) total score, in the W0-W12 period (baseline to 12 weeks)
- Secondary Outcome Measures
Name Time Method 1. Hamilton Anxiety (HAM-A) items from baseline to W12 (week 12)<br>2. Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I) scores 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)