Efficacy and safety of three dose regimens of agomelatine versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe major depressive disorder.
- Conditions
- Major Depressive DisorderMedDRA version: 13.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2009-011238-84-FI
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 520
Inclusion Criteria
Out-patients of both genders - Aged between 18 (or minimum legal age) and 65 years (inclusive) - fulfilling DSM-IV criteria for Major Depressive Disorder
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 520
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Women of childbearing potential without effective contraception, - Other types of depression than MDD, - Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Short-term efficacy (HAM-D) of 3 dose regimens of agomelatine versus placebo.;Secondary Objective: Short-term and long term efficacy and safety of 3 dose regimens of agomelatine.;Primary end point(s): HAM-D total score;Timepoint(s) of evaluation of this end point: on the week 0 - week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. HAM-D items<br>2. Clinical Global Impression scale<br>3. Sheehan Disability Scale<br>4. Hospital Anxiety and Depression Scale<br>5. Safety;Timepoint(s) of evaluation of this end point: 1. HAM-D items, from baseline to week 24<br>2. Clinical Global Impression scale, from baseline to week 6 and 24<br>3. Sheehan Disability Scale, from baseline to week 6 and 24<br>4. Hospital Anxiety and Depression Scale, from baseline to week 6<br>5. Safety from baseline to week 6 and 24