CClinicalTrials.gg
Sign In
CompletedNCT00974155EMCUpdated Apr 1, 2015

The Early Medication Change (EMC) Trial

A Phase 4 interventional study of Escitalopram, venlafaxine, lithium and Escitalopram, venlafaxine in Depression, sponsored by K. Lieb. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-01.

Sponsored by K. Lieb · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
889
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Depression

Browse trials for

Keywords

  • Major
  • Depression
  • Disorder
03

In context

Depression

8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 889 is above the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

K. Lieb is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
889 participants (actual)

Study arms

  • Experimental
    EMC (Early Medication Change)

    Drug: Escitalopram, venlafaxine, lithium

  • Active comparator
    TAU (Therapy As Usual)

    Drug: Escitalopram, venlafaxine

Interventions

  • DrugEscitalopram, venlafaxine, lithium

    oral application, highest tolerable dose, once daily

  • DrugEscitalopram, venlafaxine

    oral application, highest tolerable dose, once daily

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • University Medical Center of the Johannes Gutenberg-University
    Mainz, Rheinland-Pfalz 55130, Germany
08

References and documents

Publications

  • Engelmann J, Murck H, Wagner S, Zillich L, Streit F, Herzog DP, Braus DF, Tadic A, Lieb K, Muller MB. Routinely accessible parameters of mineralocorticoid receptor function, depression subtypes and response prediction: a post-hoc analysis from the early medication change trial in major depressive disorder. World J Biol Psychiatry. 2022 Oct;23(8):631-642. doi: 10.1080/15622975.2021.2020334. Epub 2022 Jan 25. PubMed 34985381 ↗
  • Engelmann J, Wagner S, Solheid A, Herzog DP, Dreimuller N, Muller MB, Tadic A, Hiemke C, Lieb K. Tolerability of High-Dose Venlafaxine After Switch From Escitalopram in Nonresponding Patients With Major Depressive Disorder. J Clin Psychopharmacol. 2021 Jan/Feb 01;41(1):62-66. doi: 10.1097/JCP.0000000000001312. PubMed 33208708 ↗
  • Dreimuller N, Lieb K, Tadic A, Engelmann J, Wollschlager D, Wagner S. Body mass index (BMI) in major depressive disorder and its effects on depressive symptomatology and antidepressant response. J Affect Disord. 2019 Sep 1;256:524-531. doi: 10.1016/j.jad.2019.06.067. Epub 2019 Jul 2. PubMed 31280076 ↗
  • Engelmann J, Wagner S, Wollschlager D, Kaaden S, Schlicht KF, Dreimuller N, Braus DF, Muller MB, Tuscher O, Frieling H, Tadic A, Lieb K. Higher BDNF plasma levels are associated with a normalization of memory dysfunctions during an antidepressant treatment. Eur Arch Psychiatry Clin Neurosci. 2020 Mar;270(2):183-193. doi: 10.1007/s00406-019-01006-z. Epub 2019 Mar 30. PubMed 30929060 ↗
  • Dreimuller N, Wagner S, Engel A, Braus DF, Roll SC, Elsner S, Tadic A, Lieb K. Predictors of the effectiveness of an early medication change strategy in patients with major depressive disorder. BMC Psychiatry. 2019 Jan 14;19(1):24. doi: 10.1186/s12888-019-2014-x. PubMed 30642308 ↗
  • Lieb K, Dreimuller N, Wagner S, Schlicht K, Falter T, Neyazi A, Muller-Engling L, Bleich S, Tadic A, Frieling H. BDNF Plasma Levels and BDNF Exon IV Promoter Methylation as Predictors for Antidepressant Treatment Response. Front Psychiatry. 2018 Oct 26;9:511. doi: 10.3389/fpsyt.2018.00511. eCollection 2018. PubMed 30459647 ↗
  • Wagner S, Helmreich I, Wollschlager D, Meyer K, Kaaden S, Reiff J, Roll SC, Braus D, Tuscher O, Muller-Dahlhaus F, Tadic A, Lieb K. Early improvement of executive test performance during antidepressant treatment predicts treatment outcome in patients with Major Depressive Disorder. PLoS One. 2018 Apr 18;13(4):e0194574. doi: 10.1371/journal.pone.0194574. eCollection 2018. PubMed 29668746 ↗
  • Wagner S, Kayser S, Engelmann J, Schlicht KF, Dreimuller N, Tuscher O, Muller-Dahlhaus F, Braus DF, Tadic A, Neyazi A, Frieling H, Lieb K. Plasma brain-derived neurotrophic factor (pBDNF) and executive dysfunctions in patients with major depressive disorder. World J Biol Psychiatry. 2019 Sep;20(7):519-530. doi: 10.1080/15622975.2018.1425478. Epub 2018 Feb 2. PubMed 29334322 ↗
  • Herzog DP, Wagner S, Ruckes C, Tadic A, Roll SC, Harter M, Lieb K. Guideline adherence of antidepressant treatment in outpatients with major depressive disorder: a naturalistic study. Eur Arch Psychiatry Clin Neurosci. 2017 Dec;267(8):711-721. doi: 10.1007/s00406-017-0798-6. Epub 2017 Apr 18. PubMed 28421334 ↗
  • Tadic A, Wagner S, Gorbulev S, Dahmen N, Hiemke C, Braus DF, Lieb K. Peripheral blood and neuropsychological markers for the onset of action of antidepressant drugs in patients with Major Depressive Disorder. BMC Psychiatry. 2011 Jan 26;11:16. doi: 10.1186/1471-244X-11-16. PubMed 21269443 ↗
  • Tadic A, Gorbulev S, Dahmen N, Hiemke C, Braus DF, Roschke J, van Calker D, Wachtlin D, Kronfeld K, Gorbauch T, Seibert-Grafe M, Lieb K; EMC Study Group. Rationale and design of the randomised clinical trial comparing early medication change (EMC) strategy with treatment as usual (TAU) in patients with major depressive disorder--the EMC trial. Trials. 2010 Feb 26;11:21. doi: 10.1186/1745-6215-11-21. PubMed 20187947 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00974155
Lead sponsor
K. Lieb
Collaborators
German Federal Ministry of Education and Research
Responsible party
K. Lieb (Study Principal Investigator, Johannes Gutenberg University Mainz) — Sponsor-investigator
First posted
Sep 10, 2009
Start date
Sep 2009
Primary completion
May 2014
Completion
May 2014
Last update
Apr 1, 2015

Study contacts

Klaus Lieb, Prof.
principal investigator · Clinic of Psychiatry and Psychotherapy Mainz

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Depression→

Other studies from this sponsor

K. Lieb

Start the discussion