Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
K. Lieb
With
German Federal Ministry of Education and Research
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
