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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.
 
ClinicalTrials.gov Identifier: NCT00974155
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : April 1, 2015
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
K. Lieb, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date  ICMJE September 9, 2009
First Posted Date  ICMJE September 10, 2009
Last Update Posted Date April 1, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
Remission from MDD on day 56, defined as a HAMD17 sum score ≤ 7, in non-improvers on day 14 [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
  • Response, defined as a HAMD17 sum score decrease ≥50% on day 56 [ Time Frame: 8 weeks ]
  • Absolute change of HAMD17 sum score [ Time Frame: 8 weeks ]
  • Remission defined as IDS score ≤ 11 on day 56 [ Time Frame: 8 weeks ]
  • Response defined as IDS score decrease ≥50% on day 56 [ Time Frame: 8 weeks ]
  • Absolute change in SF12 subscales "physical component score" and "mental component score" [ Time Frame: 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 ]
  • Time to remission and time to response according to IDS and HAMD17 [ Time Frame: 8 weeks ]
  • Occurrence of adverse events, UKU ratings at all visits, relevant laboratory data and deviations from normal ECG [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Early Medication Change (EMC) Trial
Official Title  ICMJE Randomised Clinical Trial Comparing Early Medication Change (EMC) Strategy With Treatment as Usual (TAU) in Patients With Major Depressive Disorder - the EMC Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Escitalopram, venlafaxine, lithium
    oral application, highest tolerable dose, once daily
  • Drug: Escitalopram, venlafaxine
    oral application, highest tolerable dose, once daily
Study Arms  ICMJE
  • Experimental: EMC (Early Medication Change)
    Intervention: Drug: Escitalopram, venlafaxine, lithium
  • Active Comparator: TAU (Therapy As Usual)
    Intervention: Drug: Escitalopram, venlafaxine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2015)
889
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2009)
640
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00974155
Other Study ID Numbers  ICMJE 2008-016
2008-008280-96 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party K. Lieb, Johannes Gutenberg University Mainz
Study Sponsor  ICMJE K. Lieb
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE
Principal Investigator: Klaus Lieb, Prof. Clinic of Psychiatry and Psychotherapy Mainz
PRS Account Johannes Gutenberg University Mainz
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP