Efficacy of agomelatine given orally on the quality of remission in elderly depressed patients, after a 12-week treatment period. A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus SSRI drug. Twelve-week treatment plus optional continuation for 12 weeks.
Not Applicable
Completed
- Conditions
- Major depressive disorderMental and Behavioural Disorders
- Registration Number
- ISRCTN68222771
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23023074
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Out-patients aged at least 60 years with recurrent major depressive episode according to diagnostic and statistical manual of mental disorders (DSM) IV
Exclusion Criteria
1. Patients treated with electroconvulsive therapy (ECT) within the last three months
2. Insight-oriented and structured psychotherapy started within the three months before inclusion
3. Light-therapy started within two weeks before inclusion
4. Current diagnosis of neurological disorders
5. Cognitive dysfunction
6. Severe or uncontrolled organic disease, likely to interfere with the conduct of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method