Randomized controlled study of early medication change for non-improvers to antidepressant therapy in major depression - The EMC trial

European Neuropsychopharmacology

Volumn 26, Issue 4, 2016, Pages 705-716

  Tadić, André ^a   Wachtlin, Daniel ^a   Berger, Mathias ^b   Braus, Dieter F ^c   van Calker, Dietrich ^b   Dahmen, Norbert ^a,d   Dreimüller, Nadine ^a   Engel, Alice ^a   Gorbulev, Stanislav ^a   Helmreich, Isabella ^a   Kaiser, Anne Katrin ^a   Kronfeld, Kai ^a   Schlicht, Konrad F ^a   Tüscher, Oliver ^a   Wagner, Stefanie ^a   Hiemke, Christoph ^a   Lieb, Klaus ^a  

^a UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^b UNIVERSITY OF FREIBURG   (Germany)

^c DR HORST SCHMIDT KLINIKEN   (Germany)

^d Hospital for Psychiatry and Psychotherapy   (Germany)

Author keywords

Antidepressant; Early improvement; Guidelines; Major Depressive Disorder; Pharmacotherapy; RCT

Indexed keywords

ESCITALOPRAM; LITHIUM; VENLAFAXINE; ANTIDEPRESSANT AGENT; CITALOPRAM; DELAYED RELEASE FORMULATION;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DRUG DOSE ESCALATION; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FAINTNESS; FEMALE; HAMILTON DEPRESSION RATING SCALE; HEADACHE; HIGH RISK POPULATION; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; REMISSION; SENSITIVITY ANALYSIS; SIDE EFFECT; SUICIDAL IDEATION; SUICIDE ATTEMPT; TREATMENT FAILURE; ADOLESCENT; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DELAYED RELEASE FORMULATION; DEPRESSIVE DISORDER, TREATMENT-RESISTANT; EARLY INTERVENTION; MIDDLE AGED; MULTICENTER STUDY; THERAPEUTIC USE; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIDEPRESSIVE AGENTS; ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; CITALOPRAM; DELAYED-ACTION PREPARATIONS; DEPRESSIVE DISORDER, TREATMENT-RESISTANT; DRUG THERAPY, COMBINATION; EARLY MEDICAL INTERVENTION; FEMALE; HUMANS; LITHIUM; MALE; MIDDLE AGED; TREATMENT OUTCOME; VENLAFAXINE HYDROCHLORIDE; YOUNG ADULT;

EID: 84960812503     PISSN: 0924977X     EISSN: 18737862     Source Type: Journal    
DOI: 10.1016/j.euroneuro.2016.02.003     Document Type: Article

References (44)

1. American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients With Major Depressive Disorder 2010, American Psychiatric Association, Washington, DC. third ed.
2. American Psychiatric Association (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) 1994, American Psychiatric Association, Washington, DC. fourth ed.
3. Bauer M., Pfennig A., Severus E., et al. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of unipolar depressive disorders, part 1: update 2013 on the acute and continuation treatment of unipolar depressive disorders. World J. Biol. Psychiatry 2013, 14:334-385.
4. Bauer M., Dell'osso L., Kasper S., et al. Extended-release quetiapine fumarate (quetiapine XR) monotherapy and quetiapine XR or lithium as add-on to antidepressants in patients with treatment-resistant major depressive disorder. J. Affect. Disord. 2013, 151:209-219.
5. Blier P., Gobbi G., Turcotte J.E., et al. Mirtazapine and paroxetine in major depression: a comparison of monotherapy versus their combination from treatment initiation. Eur. Neuropsychopharmacol. 2009, 19:457-465.
6. Blier P., Ward H.E., Tremblay P., et al. Combination of antidepressant medications from treatment initiation for major depressive disorder: a double-blind randomized study. Am. J. Psychiatry 2010, 167:281-288.
7. Carpenter L.L., Yasmin S., Price L.H. A double-blind, placebo-controlled study of antidepressant augmentation with mirtazapine. Biol. Psychiatry 2002, 51:183-188.
8. DGPPN B.Ä.K., KBV, et al. S3-Leitlinie/Nationale VersorgungsLeitlinie Unipolare Depression-Langfassung (in German) 2009, DGPPN, ÄZQ, AWMF, Berlin, Düsseldorf, Germany. first ed.
9. Fournier J.C., DeRubeis R.J., Hollon S.D., et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA 2010, 303:47-53.
10. Frank E., Prien R.F., Jarrett R.B., et al. Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse and recurrence. Arch. Gen. Psychiatry 1991, 48:851-855.
11. Fydrich T., Renneberg B., Schmitz B., Wittchen H.U. Strukturiertes Klinisches Interview für DSM-IV, Achse II (SKID-II) 1997, Hogrefe, Göttingen, Germany.
12. Greenberg P.E., Kessler R.C., Birnbaum H.G., et al. The economic burden of depression in the United States: how did it change between 1990 and 2000?. J. Clin. Psychiatry 2003, 64:1465-1475.
13. Hamilton M. A rating scale for depression. J. Neurol. Neurosurg. Psychiatry 1960, 23:56-62.
14. Henkel V., Seemüller F., Obermeier M., et al. Does early improvement triggered by antidepressants predict response/remission? Analysis of data from a naturalistic study on a large sample of inpatients with major depression. J. Affect. Disord. 2009, 115:439-449.
15. Hennings J.M., Owashi T., Binder E.B., et al. Clinical characteristics and treatment outcome in a representative sample of depressed inpatients-findings from the Munich Antidepressant Response Signature (MARS) project. J. Psychiatr. Res. 2009, 43:215-229.
16. Hiemke C., Baumann P., Bergemann N., et al. AGNP consensus guidelines for therapeutic drug monitoring in psychiatry: update 2011. Pharmacopsychiatry 2011, 44:195-235.
17. Katz M.M., Tekell J.L., Bowden C.L., et al. Onset and early behavioral effects of pharmacologically different antidepressants and placebo in depression. Neuropsychopharmacology 2004, 29:566-579.
18. Kessler R.C., Berglund P., Demler O., et al. National comorbidity survey replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA 2003, 289:3095-3105.
19. Khan A., Brown W.A. Antidepressants versus placebo in major depression: an overview. World Psychiatry 2015, 14:294-300.
20. Kirsch I., Deacon B.J., Huedo-Medina T.B., et al. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008, 5(2):e45.
21. Lam R.W., Kennedy S.H., Grigoriadis S., et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for the management of major depressive disorder in adults. III. Pharmacother. J. Affect. Disord. 2009, 117(Suppl. 1):S26-S43.
22. Lingjaerde O., Ahlfors U.G., Bech P., et al. The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr. Scand. 1987, 334(Suppl.):1-100.
23. Murray C.J., Vos T., Lozano R., et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012, 380:2197-2223.
24. Nakajima S., Uchida H., Suzuki T., et al. Is switching antidepressants following early nonresponse more beneficial in acute-phase treatment of depression?: a randomized open-label trial. Prog. Neuropsychopharmacol. Biol. Psychiatry 2011, 35:1983-1989.
25. National Institute for Care and Health Excellence, 2010. The Treatment and Management of Depression in Adults (NICE Clinical Guidelines, No. 90; Updated Edition). National Collaborating Centre for Mental Health (UK), British Psychological Society. Leicester (UK).
26. Nierenberg A.A., Farabaugh A.H., Alpert J.E., et al. Timing of onset of antidepressant response with fluoxetine treatment. Am. J. Psychiatry 2000, 157:1423-1428.
27. Papakostas G.I., Perlis R.H., Scalia M.J., et al. A meta-analysis of early sustained response rates between antidepressants and placebo for the treatment of major depressive disorder. J. Clin. Psychopharmacol. 2006, 26:56-60.
28. Posternak M.A., Zimmerman M. Is there a delay in the antidepressant effect? A meta-analysis. J. Clin. Psychiatry 2005, 66:148-158.
29. Rush A.J., Carmody T., Reimitz P.E. The inventory of depressive symptomatology (IDS): clinician (IDS-C) and self-report (IDS-SR) ratings of depressive symptoms. Int. J. Methods Psychiatr. Res. 2000, 9:45-59.
30. Rush A.J., Trivedi M.H., Wisniewski S.R., et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am. J. Psychiatry 2006, 163:1905-1917.
31. Sheehan D.V., Lecrubier Y., Sheehan K.H., et al. The mini-international neuropsychiatric interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J. Clin. Psychiatry 1998, 59(Suppl. 20):22-33.
32. Sobocki P., Jönsson B., Angst J., Rehnberg C. Cost of depression in Europe. J. Ment. Health Policy Econ. 2006, 9:87-98.
33. Stassen H.H., Angst J., Hell D., et al. Is there a common resilience mechanism underlying antidepressant drug response? Evidence from 2848 patients. J. Clin. Psychiatry 2007, 68:1195-1205.
34. Szegedi A., Müller M.J., Anghelescu I., et al. Early improvement under mirtazapine and paroxetine predicts later stable response and remission with high sensitivity in patients with major depression. J. Clin. Psychiatry 2003, 64:413-420.
35. Szegedi A., Jansen W.T., van Willigenburg A.P., et al. Early improvement in the first 2 weeks as a predictor of treatment outcome in patients with major depressive disorder: a meta-analysis including 6562 patients. J. Clin. Psychiatry 2009, 70:344-353.
36. Tadić A., Gorbulev S., Dahmen N., et al. 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, 11:21.
37. Tadić A., Helmreich I., Mergl R., et al. Early improvement is a predictor of treatment outcome in patients with mild major, minor or subsyndromal depression. J. Affect. Disord. 2010, 120:86-93.
38. Taylor M.J., Freemantle N., Geddes J.R., Bhagwagar Z. Early onset of selective serotonin reuptake inhibitor antidepressant action: systematic review and meta-analysis. Arch. Gen. Psychiatry 2006, 63:1217-1223.
39. Trivedi M.H., Rush A.J., Ibrahim H.M. The inventory of depressive symptomatology, clinician rating (IDS-C) and self-report (IDS-SR), the quick inventory of depressive symtomatology, clinician rating (QIDS-C) and self-report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation. Psychol. Med. 2004, 34:73-82.
40. van Calker D., Zobel I., Dykierek P., et al. Time course of response to antidepressants: predictive value of early improvement and effect of additional psychotherapy. J. Affect. Disord. 2009, 114:243-253.
41. Wagner S., Helmreich I., Lieb K., Tadić A. Standardized rater training for the Hamilton Depression Rating Scale (HAMD-17) and the inventory of depressive symptoms (IDS-C30). Psychopathology 2011, 44:68-70.
42. Wittchen H.U., Jacobi F., Rehm J., et al. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur. Neuropsychopharmacol. 2011, 21:655-679.
43. Zhou X., Keitner G.I., Qin B., et al. Atypical antipsychotic augmentation for treatment-resistant depression: a systematic review and network meta-analysis. Int. J. Neuropsychopharmacol 2015, epub ahead of print. 10.1093/ijnp/pyv060.
44. Zhou X., Ravindran A.V., Qin B., et al. Comparative efficacy, acceptability, and tolerability of augmentation agents in treatment-resistant depression: systematic review and network meta-analysis. J. Clin. Psychiatry 2015, 76:e487-e498.