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The Early Medication Change (EMC) Trial (EMC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00974155
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : April 1, 2015
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
K. Lieb, Johannes Gutenberg University Mainz

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Escitalopram, venlafaxine, lithium Drug: Escitalopram, venlafaxine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 889 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Clinical Trial Comparing Early Medication Change (EMC) Strategy With Treatment as Usual (TAU) in Patients With Major Depressive Disorder - the EMC Trial
Study Start Date : September 2009
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: EMC (Early Medication Change) Drug: Escitalopram, venlafaxine, lithium
oral application, highest tolerable dose, once daily

Active Comparator: TAU (Therapy As Usual) Drug: Escitalopram, venlafaxine
oral application, highest tolerable dose, once daily

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Response, defined as a HAMD17 sum score decrease ≥50% on day 56 [ Time Frame: 8 weeks ]
  2. Absolute change of HAMD17 sum score [ Time Frame: 8 weeks ]
  3. Remission defined as IDS score ≤ 11 on day 56 [ Time Frame: 8 weeks ]
  4. Response defined as IDS score decrease ≥50% on day 56 [ Time Frame: 8 weeks ]
  5. Absolute change in SF12 subscales "physical component score" and "mental component score" [ Time Frame: 8 weeks ]
  6. Remission from MDD, defined as a HAMD17 sum score ≤ 7 on day 56 (subgroups of improvers on day 14) [ Time Frame: 8 weeks ]
  7. Time to remission and time to response according to IDS and HAMD17 [ Time Frame: 8 weeks ]
  8. Occurrence of adverse events, UKU ratings at all visits, relevant laboratory data and deviations from normal ECG [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00974155

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University Medical Center of the Johannes Gutenberg-University
Mainz, Rheinland-Pfalz, Germany, 55130
Sponsors and Collaborators
K. Lieb
German Federal Ministry of Education and Research
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Principal Investigator: Klaus Lieb, Prof. Clinic of Psychiatry and Psychotherapy Mainz
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: K. Lieb, Study Principal Investigator, Johannes Gutenberg University Mainz Identifier: NCT00974155    
Other Study ID Numbers: 2008-016
2008-008280-96 ( EudraCT Number )
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by K. Lieb, Johannes Gutenberg University Mainz:
Additional relevant MeSH terms:
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Behavioral Symptoms
Venlafaxine Hydrochloride
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin and Noradrenaline Reuptake Inhibitors