the early medication change (emc) trial

Conditions: Depression

Summary: the emc trial investigates for the first time prospectively whether major depression disorder patients with non-improvement after 14 days of antidepressive treatment with emc are more likely to become remitters compared to patients treated according to current guidelines, i.e., with a medication change after 28 days of treatment in case of non-response.


Eligibility criteria:
inclusion criteria: * major depressive disorder (mdd), first episode or recurrent, according to dsm-iv * 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. exclusion criteria: * 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 * 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 * 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 the 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 4 weeks or cpl 195-400 ng/ml for four weeks without response, i.e. a symptom reduction ≥ 50% between start and end of treatment; * ad lithium: treatment with cpl 0.6-0.8 mmol li+ for four weeks without response, i.e. a symptom reduction ≥ 50% between start and end of treatment * history of medical or psychological condition, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or render the patient at high risk from treatment complications * 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

Keywords: major depression disorder