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.

aboratorios Servier S.L. (For Spain only)0 个研究点目标入组 500 人开始时间: 2006年4月3日最近更新: 2021年9月7日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 500

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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

排除标准

•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.

研究者

发起方

aboratorios Servier S.L. (For Spain only)

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