The Early Medication Change (EMC) Trial (EMC)

March 31, 2015 updated by: K. Lieb

Randomised Clinical Trial Comparing Early Medication Change (EMC) Strategy With Treatment as Usual (TAU) in Patients With Major Depressive Disorder - the EMC Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

889

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55130
        • University Medical Center of the Johannes Gutenberg-University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

K. Lieb

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Klaus Lieb, Prof., Clinic of Psychiatry and Psychotherapy Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-016
  • 2008-008280-96 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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