Severe Major Depressive Disorder MedDRA version: 3.3 Level: P.T. Classification code 10025453
Conditions
Interventions
Product Name: S20098
Product Code: S20098
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Agomelatine
CAS Number: 138112-76-2
Sponsors
Institut de Recherches Internationales Servier
Laboratorios Servier S.L. (For Spain only)
SERVIER Research and Development ICTR (For United Kingdom only)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the agomelatine superiority to fluoxetine, using the Hamilton Depression Rating Scale 17 items, after a 8-week treatment in out-patients suffering from severe Major Depressive Disorder. ; Secondary Objective: To provide additional sleep, anxiety and safety data on agomelatine in this population. ; Primary end point(s): The primary objective is to assess the agomelatine superiority to fluoxetine after a 8-week treatment period. The primary efficacy criterion is : HAM-D-17 total score. The secondary efficacy criteria are : - severity of illness, Global improvement, issued from CGI scale, - LSEQ scores, - HAM-A scores. Safety criteria : - Adverse events, - Laboratory parameters, - Blood pressure, heart rate, - Body weight and BMI, - ECG. | — |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed