EUCTR2008-008280-96-DE进行中（未招募）不适用
Randomised clinical trial comparing early medication change (EMC) strategy with treatment as usual (TAU) in patients with Major Depressive Disorder – the EMC trial. - EMC
Department of Psychiatry and Psychotherapy, University of Mainz0 个研究点目标入组 940 人开始时间: 2009年7月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 940
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
- •Major Depressive Disorder (MDD), first episode or recurrent, according to DSM-IV
- •A HAMD17 score of =18 pts.
- •Age between 18 and 65 years and age = 60 years at the time of the first depressive episode
- •Ability of subject to understand character and individual consequences of clinical trial
- •Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
- •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 940
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Acute risk of suicide needing an intervention not comprised by protocol treatment (e.g. electroconvulsive therapy)
- •Patients with a lifetime DSM-IV diagnosis of dementia, schizophrenia, schizoaffective disorder, bipolar disorder
- •Patients with a current DSM-IV diagnosis of posttraumatic stress disorder, obsessive-compulsive disorder, anxiety disorder, or eating disorder and the requirement of a treatment not comprised by protocol treatment.
- •Patients with DSM-IV substance dependency requiring acute detoxification.
- •Depression due to organic brain disorder, e.g. Multiple Sclerosis and Parkinson’s Disease
- •Women who are pregnant, breastfeeding or planning to become pregnant during the trial
- •Women who are not sterile by surgery or for more than two years postmenopausal or women with childbearing potential who not practicing a medically accepted contraception during trial (reliable contraception are systemic contraceptives (oral, implant, injection), diaphragm or condoms with spermicide, sexual abstinence)
- •A clear history of non-response to an adequate treatment trial in the current major depressive episode to any protocol antidepressant
- •Patients currently taking antidepressant medication, which has been started within the 2-4 weeks prior to study begin and a continuation of this antidepressant medication is clinically indicated
- •Medical or psychological condition that contraindicates the use of an investigational drug
- •History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- •Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Such conditions may include gastrointestinal, cardiovascular, vascular disease (particularly brady- and tachyarrhythmia, QT interval prolongation, congenital long QT syndrome, Torsades de pointes, heart failure NYHA class IV, myocardial infarction), pulmonary/respiratory, hepatic impairment, renal, metabolic diseases (particularly hypokalaemia or hypomagnesaemia), endocrinological, neurological, immune-deficiency, hematopoietic disease, or malignancies as determined by medical history, physical examination, or laboratory tests.
- •Participation in other clinical trials during the present clinical trial or within the last 6 months
- •Medical or psychological condition that would not permit signing of informed consent
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