Initiation of agomelatine after antidepressant treatment by SSRI or SNRI in outpatients suffering Major Depressive Disorder.A 3-week, randomised, double then single-blind, controlled, parallel groups, international, multicentre safety study with a 5-week open extension period.

Institut de Recherches Internationales Servier0 个研究点目标入组 300 人开始时间: 2010年9月7日最近更新: 2017年8月21日

研究概览

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•-Male or female outpatients,
•-Aged between 18 and 65 years,
•-Fulfilling DSM-IV TR criteria for Major Depressive Episode of moderate or severe intensity,
•-Diagnosis documented using the brief structured interview M.I.N.I.,
•-Clinical Global Impression item 1: CGI severity of illness = 4 (= from moderately ill to extremely ill),
•-Hospital Anxiety and Depression scale (HAD) completed,
•-Treated with either paroxetine or venlafaxine at therapeutic doses continuously for at least 6 weeks,
•-Requiring a change in antidepressant treatment due to an insufficient treatment efficacy with or without acceptability problems.
•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 300
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Patient fulfilling DSM-IV-TR criteria for a Major Depressive Episode of mild intensity and/or episode with
•psychotic features, catatonic features or with duration < 6 weeks,
•-All types of mood disorder other than Major Depressive Disorder, according to DSM-IV TR criteria,
•-Patient treated within 2 weeks before selection visit with either paroxetine or venlafaxine, but in association with
•another antidepressant drug for more than 3 days,
•-High Suicidality” according to MINI 5.0.0.,
•-Marked suicidal intent and/or suicidal risk for the current episode, according to the investigator's opinion,
•-Women of childbearing potential without effective contraception,
•-Pregnant or breast-feeding women,
•-Patients treated within the 4 weeks before selection visit with either an antipsychotic or a barbiturate,
•- Patients treated with a depot antipsychotic within 2 injection-period time before selection visit,
•-Patient treated within the 2 weeks before selection visit with a benzodiazepine at a dose which is superior to the maximum recommended dosage,
•-Hepatic impairment.

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