NCT00974155CompletedPhase 4
Randomised Clinical Trial Comparing Early Medication Change (EMC) Strategy With Treatment as Usual (TAU) in Patients With Major Depressive Disorder - the EMC Trial
K. Lieb1 site in 1 country889 target enrollmentStarted: September 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 889
- Locations
- 1
- Primary Endpoint
- Remission from MDD on day 56, defined as a HAMD17 sum score ≤ 7, in non-improvers on day 14 (n=192)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
EMC (Early Medication Change)
Experimental
Intervention: Escitalopram, venlafaxine, lithium (Drug)
TAU (Therapy As Usual)
Active Comparator
Intervention: Escitalopram, venlafaxine (Drug)
Outcomes
Primary Outcomes
Remission from MDD on day 56, defined as a HAMD17 sum score ≤ 7, in non-improvers on day 14 (n=192)
Time Frame: 8 weeks
Secondary Outcomes
- 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)
Investigators
K. Lieb
Study Principal Investigator
Johannes Gutenberg University Mainz
Study Sites (1)
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