The Early Medication Change (EMC) Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
K. Lieb, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00974155
First received: September 9, 2009
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Depression
Drug: Escitalopram, venlafaxine, lithium
Drug: Escitalopram, venlafaxine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Remission from MDD on day 56, defined as a HAMD17 sum score ≤ 7, in non-improvers on day 14 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response, defined as a HAMD17 sum score decrease ≥50% on day 56 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Absolute change of HAMD17 sum score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Remission defined as IDS score ≤ 11 on day 56 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Response defined as IDS score decrease ≥50% on day 56 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Absolute change in SF12 subscales "physical component score" and "mental component score" [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Remission from MDD, defined as a HAMD17 sum score ≤ 7 on day 56 (subgroups of improvers on day 14) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Time to remission and time to response according to IDS and HAMD17 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Occurrence of adverse events, UKU ratings at all visits, relevant laboratory data and deviations from normal ECG [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 940
Study Start Date: September 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974155

Locations
Germany
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
Investigators
Principal Investigator: Klaus Lieb, Prof. Clinic of Psychiatry and Psychotherapy Mainz
  More Information

Additional Information:
No publications provided by Johannes Gutenberg University Mainz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: K. Lieb, Study Principal Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT00974155     History of Changes
Other Study ID Numbers: 2008-016, 2008-008280-96
Study First Received: September 9, 2009
Last Updated: May 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
Major
Depression
Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Lithium
Venlafaxine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 18, 2014