drugset / Trial / NCT00974155
The Early Medication Change (EMC) Trial
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-09
- Primary completion
- 2014-05
- Completion
- 2014-05
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Escitalopram | Small molecule | — | Oral |
| Subject | Lithium | Unknown | — | Oral |
| Subject | Venlafaxine | Small molecule | — | Oral |