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DepressionPhase 4EMCNCT00974155

The Early Medication Change (EMC) Trial

A Phase 4 study testing Escitalopram, venlafaxine, lithium and Escitalopram, venlafaxine in people with Depression, run by K. Lieb at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression
What is being tested?
Escitalopram, venlafaxine, lithium and Escitalopram, venlafaxine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
889 participants
Where
1 siteGermany
Study dates
Sep 2009to May 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center of the Johannes Gutenberg-University

    Mainz, Rhineland-Palatinate, 55130

Other trials in Germany

About this study

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

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.

Conditions
Depression
Being tested
Escitalopram, venlafaxine, lithium, Escitalopram, venlafaxine
Keywords
Major, Depression, Disorder
Medical subject headings
Depression, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Escitalopram, venlafaxine, lithiumDrug

    oral application, highest tolerable dose, once daily

  • Escitalopram, venlafaxineDrug

    oral application, highest tolerable dose, once daily

Study groups in NCT00974155
Study groupRoleWhat they receive
EMC (Early Medication Change)ExperimentalNot described
Receives: Drug: Escitalopram, venlafaxine, lithium
TAU (Therapy As Usual)Active comparatorNot described
Receives: Drug: Escitalopram, venlafaxine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission from MDD on day 56, defined as a HAMD17 sum score ≤ 7, in non-improvers on day 14 (n=192)

    Measured: 8 weeks

Secondary outcomes (8)

  1. Response, defined as a HAMD17 sum score decrease ≥50% on day 56

    Measured: 8 weeks

  2. Absolute change of HAMD17 sum score

    Measured: 8 weeks

  3. Remission defined as IDS score ≤ 11 on day 56

    Measured: 8 weeks

  4. Response defined as IDS score decrease ≥50% on day 56

    Measured: 8 weeks

  5. Absolute change in SF12 subscales "physical component score" and "mental component score"

    Measured: 8 weeks

  6. Remission from MDD, defined as a HAMD17 sum score ≤ 7 on day 56 (subgroups of improvers on day 14)

    Measured: 8 weeks

  7. Time to remission and time to response according to IDS and HAMD17

    Measured: 8 weeks

  8. Occurrence of adverse events, UKU ratings at all visits, relevant laboratory data and deviations from normal ECG

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
889 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00974155
Sponsor's protocol ID
2008-016
Other IDs
2008-008280-96, 2008
Acronym
EMC
Status last verified
Mar 2015
First submitted
9 Sep 2009
Last updated
1 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Engelmann J, Solheid A, Wagner S, Quesada Ocete BP, Herzog DP, Dreimuller N, Kachel KM, Muller MB, Tadic A, Braus DF, Hiemke C, Lieb K. Heart Rate-Corrected QT Interval Dynamics Following Antidepressant Switching from Escitalopram to High-Dose Venlafaxine: Cardiac Safety Insights from the Early Medication Change Cohort. Pharmacopsychiatry. 2026 Feb 26. doi: 10.1055/a-2793-9711. Online ahead of print.

    PubMed 41748094

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Escitalopram, venlafaxine, lithium and Escitalopram, venlafaxine in people with Depression, run by K. Lieb at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00974155, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.

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The Early Medication Change (EMC) Trial (NCT00974155) | AzTrials