Major Depressive Disorder MedDRA version: 3.3 Level: P.T. Classification code 10025453
Conditions
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria - Out-patients - Fulfilling DSM IV-TR criteria for Major Depressive Disorder (appendix 3) of moderate or severe intensity: - Recurrent episode and at the beginning of the index episode patients must have been free of depressive symptoms of their previous episode for at least 6 months, - With or without melancholic features according DSM IV-TR criteria (appendix 9), - Without seasonal pattern according DSM IV-TR criteria (appendix 10), - Without psychotic features, - Without post partum onset for the current episode, - Current episode >or= 8 weeks. Inclusion Criteria For The Open Period: - HAM-D 17-item score still >or= 22 and decrease (if any) between ASSE and W0 = 20%. - Sum of items H1+H2+H5+H6+H7+H8+H10+H13 of HAM-D 17-item >or= 55% HAM-D 17-item total score. - CGI item 1: Severity of illness >or= 4 (moderately ill to severely ill). Randomisation criteria For The Double Blind Period: - Patients having completed the 8 to 10 weeks of “open” treatment. - Patients improved by agomelatine 25 mg or 50 mg after 8 to 10 weeks of “open” treatment. 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
Exclusion criteria
Exclusion criteria: Non selection Criteria - All types of depression other than Major Depressive Disorder - Severe or uncontrolled organic disease, likely to interfere with the conduct of the study (e.g. neoplasic, cardiovascular, pulmonary and digestive disorders, unstabilized diabetes of type I or II, untreated or uncontrolled clinically significant arterial hypertension). Patients whose state is stabilized under treatment may be included. Non Inclusion Criteria For The Open Period: - Any non-selection criteria which could have appeared after the selection visit. - Any clinically relevant abnormality detected during the physical examination, ECG or laboratory test likely to interfere with the study conduct or evaluation. - Positive pregnancy test. - gGT or transaminases values > 3 times the upper limit or blood creatinin > 150 mmol/l. - IVRS refusal. Non randomisation Criteria: - IVRS refusal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of agomelatine (25 mg/50 mg), in the prevention of depressive relapse, in ambulatory patients suffering from Major Depressive Disorder, during 24 weeks of treatment after an initial response to agomelatine 25 mg or 50 mg.;Secondary Objective: To provide additional safety data on long term use of agomelatine.;Primary end point(s): Primary efficacy criterion = relapse defined as: - HAM-D 17-item total score = 16 - or any withdrawal for lack of efficacy during the double-blind period according to the clinical opinion of the investigators. It should be based on the evolution of both Hamilton and Clinical Global Impression scores and reviewed at the end of the study by the Coordinator's Committee. - or suicide/attempt according to the opinion of the Coordinators Committee at the end of the study. Main expression of the primary efficacy criterion : time to relapse (days) | — |
Countries
Finland, United Kingdom
Outcome results
None listed