Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder. A randomised double-blind, parallel groups, international study versus fluoxetine (20 mg/day with potential adjustment to 40 mg) with a double-blind extension period of 16 weeks.
- Conditions
- Severe Major Depressive DisorderMedDRA version: 3.3 Level: P.T. Classification code 10025453
- Registration Number
- EUCTR2004-004008-19-GB
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
Selection criteria :
male or female out-patients, aged of 18 (or minimum legal age) to 65 years (both inclusive),
- Fulfilling DSM-IV-TR criteria for Major Depressive Disorder, of severe intensity (HAM-D-17 total score greater than or equal to 25 and CGI severity of illness greater than or equal to 4):
. single or recurrent episode > or = 4 weeks
. with or without melancholic features,
. without seasonal pattern,
. without psychotic features,
. without post partum onset.
- All other concomitant psychiatric disorders are not allowed and will be documented using the brief structured interview MINI
- Requiring an antidepressant treatment
Inclusion criteria :
- The investigator will check during the inclusion visit that all selection criteria are still fulfilled,
- HAM-D-17 items total score greater than or equal to 25 without a decrease from selection visit more than 20%,
- Sum of items H1, H2, H5, H6, H7, H8, H10 and H13 of HAM-D-17 greather than or equal to 55% of HAM-D-17 total score at W0,
- CGI item 1 still greater or equal to 4,
- Available laboratory tests and 12-lead ECG results for the inclusion visit,
- Physical examinations (BP, HR, body weight) performed at inclusion visit.
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) no
F.1.3.1 Number of subjects for this age range
Non-selection criteria related to depression :
- All types of depression other than Major Depressive Disorder, including Bipolar Disorder I and II, Double Depression (Major Depressive Disorder and Dysthymic Disorder), chronic depression (defined as depression with a duration of the episode longer than 2 years), Schizoaffective Disorder of depressive type, depression with psychotic features,
- Current depressive episode having not responded to 2 different previous antidepressant treatments of at least 4 weeks for each one at an appropriate dose (including fluoxetine),
- Marked suicidal intent and/or known suicidal tendencies for the current episode defined as a score of 4 at the item 3 of the HAM-D-17 or the investigator's opinion based on the patient’s medical history, previous suicide attempts, quality of social and familial support,
- Patient treated with ECT within the last 3 months before selection or requiring ECT at present (according to investigator’s clinical judgment),
- Insight-oriented and structured psychotherapy (interpersonal therapy, psychoanalysis, cognitive behavioural therapy) started within the 3 months before selection,
- Light-therapy received within 2 weeks before selection,
Non-inclusion criteria :
- Any non-selection criteria which could have appeared after the selection visit,
- Any clinically relevant abnormality detected during the physical examination, ECG or laboratory tests likely to interfere with the study conduct or evaluations,
- gGT or transaminases values > 3 times the upper limit or/and creatininemia > 150 mmol/l.
- Treatment with thyroid hormones started, stopped or modified within 3 months prior to inclusion. They should remain at a stable dose until W8 visit,
- Menopause hormone replacement therapy started, stopped or modified within 3 months prior to inclusion. They should remain at a stable dose until W8 visit,
- b-blockers started, stopped or modified within 4 weeks prior to inclusion. They should remain at a stable dose until W8 visit.
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