The Early Medication Change (EMC) Trial
- Conditions
- Depression
- Interventions
- Drug: Escitalopram, venlafaxine, lithium
- Registration Number
- NCT00974155
- Lead Sponsor
- K. Lieb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 889
- 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.
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Acute risk of suicide needing an intervention not comprised by protocol treatment (e.g. electroconvulsive therapy)
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Patients with a lifetime DSM-IV diagnosis of dementia, schizophrenia, schizoaffective disorder, bipolar disorder
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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
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Patients with DSM-IV substance dependency requiring acute detoxification
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Depression due to organic brain disorder, e.g. Multiple Sclerosis and Parkinson's Disease
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Women who are pregnant, breastfeeding or planning to become pregnant during the trial
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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
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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
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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
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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
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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
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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
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Participation in other clinical trials during the present clinical trial or within the last 6 months
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Medical or psychological condition that would not permit signing of informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAU (Therapy As Usual) Escitalopram, venlafaxine - EMC (Early Medication Change) Escitalopram, venlafaxine, lithium -
- Primary Outcome Measures
Name Time Method Remission from MDD on day 56, defined as a HAMD17 sum score ≤ 7, in non-improvers on day 14 (n=192) 8 weeks
- Secondary Outcome Measures
Name Time Method Absolute change in SF12 subscales "physical component score" and "mental component score" 8 weeks Absolute change of HAMD17 sum score 8 weeks Remission defined as IDS score ≤ 11 on day 56 8 weeks Time to remission and time to response according to IDS and HAMD17 8 weeks Occurrence of adverse events, UKU ratings at all visits, relevant laboratory data and deviations from normal ECG 8 weeks Remission from MDD, defined as a HAMD17 sum score ≤ 7 on day 56 (subgroups of improvers on day 14) 8 weeks Response, defined as a HAMD17 sum score decrease ≥50% on day 56 8 weeks Response defined as IDS score decrease ≥50% on day 56 8 weeks
Trial Locations
- Locations (1)
University Medical Center of the Johannes Gutenberg-University
🇩🇪Mainz, Rheinland-Pfalz, Germany