DRKS00000320已完成4 期
Randomised clinical trial comparing early medication change (EMC) strategy with treatment as usual (TAU) in patients with Major Depressive Disorder- the EMC trial. - The Early Medication Change (EMC) Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 928
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 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. (Rationale: Although there exist different cut-offs for mild to moderate depression varying between 13/14-17/18 pts., the cut-off of >=18 pts. is the most often used in clinical trials and assures the inclusion of at least moderately depressed patients).
- •-Age between 18 and 65 years and age <= 60 years at the time of the first depressive episode. (Rationale: This age range assures the inclusion of patients with early-onset depression in contrast to late-onset depression, for which different pathophysiological mechanisms have been suggested. In addition, the vast majority of studies on the predictive value of early improvement included patients aged <= 65 years).
- •-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.
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 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 including Multiple Sclerosis and Parkinsons 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. A clear history of non-response has to be assumed, when to following criteria are fulfilled:
- •-ad Escitalopram: Treatment with a mDDD 15 mg/d for 4 weeks or CPL 15-80 ng/ml for four weeks without response, i.e. a symptom reduction >= 50% between start and end of treatment.
- •-ad Venlafaxine: Treatment with a mDDD 300 mg/d for weeks 4 weeks or CPL 195-400 ng/ml for four weeks without response
- •-ad Lithium: Treatment with CPL 0.6-0.8 mmol Li+ for four weeks without response
- •-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, pulmonary/respiratory, hepatic impairment, renal, metabolic diseases, 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.
研究者
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