Major Depressive Disorder MedDRA version: 3.3 Level: P.T. Classification code 10025453
Conditions
Sponsors
Institut de Recherches Internationales Servier
Laboratorios Servier S.L. (For Spain only)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria: Demographic characteristics: Outpatients of both genders, aged at least 60, fulfilling DSM-IV TR criteria for Major Depressive Disorder, recurrent episode with a score HAM-D-17 > or = 22. Diagnosis criteria : The clinical examination performed at selection visit will check the following patients characteristics : -Fulfilling DSM-IV TR criteria for Major Depressive Disorder of moderate or severe intensity: recurrent episode (at least one previous episode) -Diagnosis documented using the brief structured interview M.I.N.I.. -Hamilton Depression Rating Scale : HAM-D 17 items total score > or = 22. -Requiring an antidepressant treatment. -Able to go untreated until the inclusion visit. Inclusion criteria: The investigator will check that the selection criteria are still fulfilled and : -Hamilton Depression Rating Scale: HAM-D 17 items total score still > or = 22 and HAMD decrease between ASSE and W0 or = 55% HAM-D total score. -Clinical Global Impression: CGI severity of illness > or = 4 (moderately ill to severely ill). -Results of laboratory tests and ECG must be available and free of any clinically significant abnormalities likely to interfere with the study conduct or evaluations. 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
Exclusion criteria: Non-selection criteria: General criteria: -Patients living in an aged care facility or in a nursing home or in long term care settings, i.e. people needing assistance in their daily life -Patients likely to become institutionalised during the study Medical and therapeutic criteria Psychiatric criteria Other Depressive Disorders : -All types of depression other than Major Depressive Disorder -Depression onset within the 3 months after a stroke, -Resistant depression (for the current episode or for the previous ones) : patients who have not responded to 2 different previous antidepressant treatments of at least 4 weeks at an appropriate dose. -Marked suicidal intent and/or known suicidal tendencies for the current episode defined as a score > or = 3 at the item of the HAM-D and the investigator’s opinion based on the patient’s medical history, previous suicide attempts, quality of social and familial support. -Patients treated with ECT (Electro Convulsive Therapy) within the last 3 months before inclusion or requiring ECT at present (according to investigator’s clinical judgement). -Insight-oriented and structured psychotherapy started within the 3 months before inclusion. -Light-therapy started within 2 weeks before inclusion. -Patients having not responded to agomelatine in a previous trial. -Patients previously not responders to paroxetine. -Other Psychiatric Disorders according to DSM-IV TR Sleep Disorders : -Known Obstructive Sleep Apnea Syndrome previously diagnosed and not treated. -Restless legs syndrome. -Shift workers. -Transmeridian flight (> or = 3 time zones) in the past 10 days before the inclusion or planned in the first 12 weeks of the study). Miscellaneous conditions : -Current diagnosis of neurological disorders : e.g. stroke, seizures, epilepsy, migraine… -Cognitive dysfunction : Mini Mental State Examination score (MMSE) 3 times the upper reference value or creatinin clearance < 50 ml/min (calculated with Cockroft’s formula) or sodium value below the lower reference value.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this trial is to assess the efficacy of agomelatine versus paroxetine on quality of the remission in elderly depressed out-patients remitted after a 12-week treatment period. Primary objective is to show that the elderly patients with remitted depression after a 12-week agomelatine treatment period have a better subjective sleep quality than those remitted after a 12-week treatment with paroxetine (remitted patients defined as responders at W10 visit, ie. HAMD-17 total score decrease > or = 50% compared to baseline, and in remission at W12, ie. HAMD-17 total score < or = 7).;Secondary Objective: Secondary objectives : - To study agomelatine and paroxetine effect on daytime drowsiness, on residual symptoms, on quality of life and on emotional responsiveness, in remitters and to provide additional safety data in this population.;Primary end point(s): Primary efficacy criterion : The superiority of agomelatine to paroxetine will be demonstrated using the “Quality of sleep” score issued from the Leeds Sleep Evaluation Questionnaire (LSEQ). | — |
Countries
Belgium, Hungary, Italy, Portugal, Spain
Outcome results
None listed