EUCTR2010-023576-10-RO进行中（未招募）1 期
Early effect of agomelatine on general interest in outpatients with Major Depressive Disorder. A 12-week, randomized, double-blind, multicentre study with parallel groups: agomelatine (25mg/day given orally with blinded potential adjustment to 50mg/day) versus escitalopram (10mg/day given orally with blinded potential adjustment to 20mg/day). - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •- Male or female outpatients
- •- Aged between 18 and 65 years (inclusive) at the time of selection
- •- Fulfilling DSM-IV-TR criteria for current Major Depressive Episode (MDE) < = 12
- •months, of moderate to severe intensity
- •- Major Depressive Episode diagnosis documented using the brief structured interview M.I.N.I.
- •- QIDS-SR16 item 13 (General interest) > = 2
- •- HAM-D-17 total score > = 22
- •- CGI-S (Severity of illness) > = 4 (moderately to severely ill)
- •- Requiring an antidepressant treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
排除标准
- •- Patient fulfilling DSM-IV-TR criteria for a MDE of mild intensity or severe episode with psychotic features, catatonic features or with duration < 4 weeks
- •- All types of depression other than MDD, according to DSM-IV-TR criteria
- •- 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 and/or in the investigator's opinion based on the patient's medical history, previous suicide attemps, quality of social and familial support
- •- Pregnancy, breastfeeding or possibility of becoming pregnant during the study and without an effective contraception.
- •- Hepatic impairment and severe renal insufficiency
- •Patients with known QT interval prolongation or congenital long QT syndrome.
- •For patients with stable cardiac disease: any clinically relevant abnormality detected during the ECG likely to interfere with the study conduct or evaluations
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