ISRCTN28327843已完成未知
Early effect of agomelatine on general interest in outpatients suffering major depressive disorder: a parallel group, randomised, double-blind, multicentre study
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 300 人开始时间: 2011年5月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female outpatients
- •2. Aged between 18 and 65 years (inclusive) at the time of selection
- •3. Fulfilling Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria for current major depressive episode (MDE) < = 12months, of moderate to severe intensity
- •4. Major depressive episode diagnosis documented using the brief structured Mini-International Neuropsychiatric Interview (M.I.N.I.)
- •5. Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) item 13 (General interest) > = 2
- •6. Hamilton Rating Scale for Depression (HAM-D-17) total score > = 22
- •7. Clinical Global Impression - Severity (CGI-S) (Severity of illness) > = 4 (moderately to severely ill)
- •8. Requiring an antidepressant treatment
排除标准
- •1. 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
- •2. All types of depression other than MDD, according to DSM-IV-TR criteria
- •3. 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, previoussuicide attempts, quality of social and familial support
- •4. Pregnancy, breastfeeding or possibility of becoming pregnant during the study and without an effective contraception
- •5. Hepatic impairment
- •6. Severe renal insufficiency
研究者
相似试验
进行中（未招募）
1 期
Comparison of Agomelatine (25 mg/day, adjustement to 50 mg/day) with Escitalopram (10mg/day, adjustement to 20 mg/day) on general interest in outpatients with Major Depressive Disorder over 12 weeks of treatmentMedDRA version: 19.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersMajor Depressive DisorderEUCTR2010-023576-10-ROInstitut de Recherches Internationales Servier
已完成
3 期
effect of Agomelatin on the migraineMigraine.Migraine without aura [common migraine]G43.0IRCT20230303057599N1Tehran University of Medical Sciences50
已完成
不适用
Evaluation of the effect of agomelatine and escitalopram on emotions and motivation in healthy male and female volunteersMental and Behavioural DisordersMajor Depressive DisorderISRCTN75872983Institut de Recherches Internationales Servier (France)128
进行中（未招募）
不适用
ong-term efficacy and safety of agomelatine in non-depressed out-patients with Generalized Anxiety Disorder.A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25mg/day with the possibility for blinded dose-adjustment to 50mg/day).Generalised anxiety disorderMedDRA version: 10.0Level: LLTClassification code 10018075Term: <Manually entered code. Term in E.1.1>EUCTR2006-005674-47-EEInstitut de Recherches Internationales Servier500
进行中（未招募）
1 期
ong-term efficacy and safety of agomelatine in non-depressed out-patients with Generalized Anxiety Disorder.A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25mg/day with the possibility for blinded dose-adjustment to 50mg/day).EUCTR2006-005674-47-DKInstitut de Recherches Internationales Servier370