Efficacy and safety of agomelatine (25 mg/day with potential adjustment at 50 mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode. An 8-week randomised, double-blind, controlled, parallel groups study followed by a double-blind extension treatment period up to 1 year.
- Conditions
- Major depressive episode in the framework of bipolar disorderMedDRA version: 7.0Level: PTClassification code 10004939
- Registration Number
- EUCTR2005-004881-17-NL
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- In or out patients of both genders,
- over 18 years old,
- fulfilling DSM-IV-TR criteria for Bipolar I disorder with current Major Depressive Episode
- Treated with a mood stabilizer (lithium or valproic acid).
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Other psychiatric conditions according to DSM-IV TR,
- Pregnancy (positive ßhCG blood test),
- Use of psychotropic medications other than lithium, valproic acid and lorazepam.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method