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Is it worth assessing progress as early as week 2 to adapt antidepressive treatment strategy? Results from a study on agomelatine and a global meta-analysis

Published online by Cambridge University Press:  15 April 2020

P. Gorwood ,
F. Bayle ,
G. Vaiva ,
P. Courtet ,
E. Corruble  and
P.-M. Llorca
P. Gorwood*
Affiliation:
Centre Hospitalier Sainte-Anne (CMME), 100, rue de la Santé, 75014Paris, France Inserm U894, University Paris-Descartes, Centre of Psychiatry and Neuroscience, 2ter, rue d'Alesia, 75014Paris, France
F. Bayle
Affiliation:
Inserm U894, University Paris-Descartes, Centre of Psychiatry and Neuroscience, 2ter, rue d'Alesia, 75014Paris, France Centre Hospitalier Sainte-Anne (SHU), 100, rue de la Santé, 75014Paris, France
G. Vaiva
Affiliation:
Pôle de psychiatrie, université Lille-Nord de France, CHRU de Lille, hôpital Michel-Fontan, 59037Lille cedex, France
P. Courtet
Affiliation:
Inserm U1061, CHRU de Montpellier, Montpellier, France
E. Corruble
Affiliation:
Inserm U669, Paris XI University, Psychiatry Department of Bicetre, University Hospital, AP—HP, 94275Le Kremlin Bicêtre, France
P.-M. Llorca
Affiliation:
CHU Clermont-Ferrand, BP 69, Clermont Université, université d'Auvergne, Clermont-Ferrand cedex 01, France
*
*Corresponding author. Tel.: +33 1 45 65 73 07; fax: +33 1 45 65 89 43. E-mail address:[email protected] (P. Gorwood).
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Abstract

Context:

A delay of 4–8 weeks before modifying the prescribed antidepressant treatment is usually proposed when incomplete treatment response is observed. A number of studies nevertheless proposed that the lack of early improvement (usually 20% decrease of severity at week 2) is predictive of the absence of subsequent treatment response, potentially saving weeks of inadequate treatment, but with no information for non-interventional studies devoted to outpatients.

Method:

Two thousand nine hundred and thirty-eight outpatients with major depressive disorder were included in a multicentre, non-interventional study, assessing at inclusion, week 2 and week 6, mood (QIDS-C, CGI, PGI and VAS) sleep (LSEQ) and functionality (SDS). All metrics at week 2 were tested for their capacity to predict response (and then remission) at week 6, all patients being treated by agomelatine. A meta-analysis of all studies (n = 12) assessing the predictive role of improvement at week 2 was also performed, assessing specific effect size of published studies and the weight of the different parameters they used.

Results:

The QIDS-C and the CGI-I were the only instruments with an area under the curve over 0.7, with different cut-offs for treatment response and remission. A decrease of more than five points at the QIDS-C had the highest positive predictive value for treatment response, and a CGI-I over three had the highest negative predictive value, which would favour relying on the clinicians for warning (too high CGI-I), and on instruments for confidence (favourable decrease of the QIDS-C). The meta-analysis of all studies also detected a large effect size of early improvement, stressing how rating week 2 severity could be beneficial in clinical practice.

Conclusions:

Previous reports stressing the interest of an assessment at week 2 were reinforced by the present results, which also defined more accurately what could be the most appropriate cut-offs, and how combining these early results could be more effective.

Keywords

Early responseTreatment responseMajor depressive disorderMarkerOutcome
Type
Original article
Information
European Psychiatry , Volume 28 , Issue 6 , August 2013 , pp. 362 - 371
Copyright
Copyright © European Psychiatric Association

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References

American Psychiatric Association. Diagnostic and statistical manual of mental disorders, Fourth ed., text revisionWashington DC: American Psychiatric Association; 2000.Google Scholar
American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder, Third editionArlington, USA: APA; 2010.Google Scholar
Anderson, IMFerrier, INBaldwin, RC, et al.Evidence-based guidelines for treating depressive disorders with antidepressants: a revision of the 2000 British Association for Psychopharmacology guidelines. J Psychopharmacol 2008;22:343–396.CrossRefGoogle ScholarPubMed
Baldwin, DStein, DDolberg, OBandelow, BHow long should a trial of escitalopram treatment be in patients with major depressive disorder, generalised anxiety disorder or social anxiety disorder? An exploration of the randomised controlled trial database. Hum Psychopharmacol Clin Exp 2009;24:269–275.CrossRefGoogle ScholarPubMed
Bares, MNovak, TKopecek, MStopkova, PKozeny, JHöschl, CThe early improvement of depressive symptoms as a potential predictor of response to antidepressants in depressive patients who failed to respond to previous antidepressant treatments. Analysis of naturalistic data. Eur Psychiatry 2012;27(7):522–527.CrossRefGoogle ScholarPubMed
Bauer, MWhybrow, PCAngst, JVersiani, MMoller, HJWorld Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of unipolar depressive disorders, part 1: acute and continuation treatment of major depressive disorder. World J Biol Psychiatry 2002;3:5–43.CrossRefGoogle ScholarPubMed
Bech, PCialdella, PHaugh, MC, et al.Meta-analysis of randomised controlled trials of fluoxetine v. placebo and tricyclic antidepressants in the short-term treatment of major depression. Br J Psychiatry 2000;176:421–428.CrossRefGoogle ScholarPubMed
Bech, PSocial functioning: should it become an endpoint in trials of antidepressants?. CNS Drugs 2005;19(4):313–324.CrossRefGoogle ScholarPubMed
Bonett, DPrice, RStatistical inference for generalized Yule coefficients in 2 × 2 contingency tables. Sociol Methods Res 2007;35:429–446.CrossRefGoogle Scholar
Casper, RCKatz, MMBowden, CLDavis, JMKoslow, SHHanin, IThe pattern of physical symptom changes in major depressive disorder following treatment with amitriptyline or imipramine. J Affect Disord 1994;31:151–164.CrossRefGoogle ScholarPubMed
Coryell, WCoppen, AZeigler, VEBiggs, JTEarly improvement as a predictor of response to amitriptyline and nortriptyline: a comparison of 2 patient samples. Psychol Med 1982;12:135–139.CrossRefGoogle ScholarPubMed
Gelenberg, AJChesen, CLHow fast are antidepressants?. J Clin Psychiatry 2000;61:712–721.CrossRefGoogle ScholarPubMed
Gorwood, PCorruble, EFalissard, BGoodwin, GMToxic effects of depression on brain function: impairment of delayed recall and the cumulative length of depressive disorder in a large sample of depressed outpatients. Am J Psychiatry 2008;165:731–739.CrossRefGoogle Scholar
Gorwood, PRestoring circadian rhythms: a new way to successfully manage depression. J Psychopharmacol 2010;24:15–19.CrossRefGoogle ScholarPubMed
Hamilton, MA rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56–62.CrossRefGoogle ScholarPubMed
Henkel, VSeemuller, FObermeier, 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.CrossRefGoogle Scholar
Hickie, IBRogers, NLNovel melatonin-based therapies: potential advances in the treatment of major depression. Lancet 2011;378(9791):621–631.CrossRefGoogle ScholarPubMed
Hirschfeld, RMDunner, DLKeitner, GKlein, DNKoran, LMKornstein, SG, et al.Does psychosocial functioning improve independent of depressive symptoms? A comparison of nefazodone, psychotherapy, and their combination. Biol Psychiatry 2002;51(2):123–133.CrossRefGoogle ScholarPubMed
Howard, KILueger, RJMaling, MSMartinovich, ZA phase model of psychotherapy outcome: causal mediation of change. J Consult Clin Psychol 1993;61(4):678–685.CrossRefGoogle Scholar
Katz, MMKoslow, SHMaas, JW, et al.The timing, specificity and clinical prediction of tricyclic drug effects in depression. Psychol Med 1987;17:297–309.CrossRefGoogle ScholarPubMed
Kennedy, SHEmsley, RPlacebo-controlled trial of agomelatine in the treatment of major depressive disorder. Eur Neuropsychopharmacol 2006;16:93–100.CrossRefGoogle ScholarPubMed
Kessler, RCAguilar-Gaxiola, SAlonso, J, et al.The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psychiatr Soc 2009;18(1):23–33.CrossRefGoogle ScholarPubMed
Kim, JMKim, SYStewart, R, et al.Improvement within 2 weeks and later treatment outcomes in patients with depressive disorders: the CRESCEND study. J Affect Disord 2011;129:183–190.CrossRefGoogle ScholarPubMed
Lam, RWKennedy, SHGrigoriadis, S, et al.Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for the management of major depressive disorder in adults. III. Pharmacotherapy. J Affect Disord 2009;117:S26–S43.CrossRefGoogle ScholarPubMed
Leuchter, AFUijtdehaage, SHCook, IAO’Hara, RMandelkern, MRelationship between brain electrical activity and cortical perfusion in normal subjects. Psychiatry Res Neuroimaging 1999;90(2):125–140.CrossRefGoogle ScholarPubMed
Li, JKuk, AYRush, AJA practical approach to the early identification of antidepressant medication non-responders. Psychol Med 2012;42(2):309–316.CrossRefGoogle ScholarPubMed
Lôo, HHale, AD’Haenen, HDetermination of the dose of agomelatine, a melatoninergic agonist and selective 5-HT(2C) antagonist, in the treatment of major depressive disorder: a placebo-controlled dose range study. Int Clin Psychopharmacol 2002;17:239–247.Google ScholarPubMed
Marangell, LBSwitching antidepressants for treatment-resistant major depression. J Clin Psychiatry 2001;62:12–17.Google ScholarPubMed
National Institute for Health Clinical Excellence. CG90 Depression in adults: NICE guidance. London: NICE; 2009.Google Scholar
National Institute of Mental Health. CGI, Clinical Global Impression. Guy, W.ECDEU Assessment Manual of Psychopharmacology Review Rockville, USA: NIMH; 1976. p. 217–222.Google Scholar
Nierenberg, AAMcLean, NEAlpert, JEWorthington, JJRosenbaum, JFFava, MEarly non-response to fluoxetine as a predictor of poor 8-week outcome. Am J Psychiatry 1995;152:1500–1503.Google Scholar
Nierenberg, AGreist, JMallinckrodt c, , Prakash, ASambunaris, ATollefson, G, et al.Duloxetine versus escitalopram and placebo in the treatment of patients with major depressive disorder: onset of antidepressant action, a non-inferiority study. Curr Med Res Opin 2007;23:401–416.CrossRefGoogle ScholarPubMed
Olesen, JGustavsson, ASvensson, MWittchen, HUJönsson, B, CDBE2010 study group, et al.The economic cost of brain disorders in Europe. Eur J Neurol 2012;19(1):155–162.CrossRefGoogle ScholarPubMed
Olié, JPKasper, SEfficacy of agomelatine, a MT1/MT2 receptor agonist with 5-HT2C antagonistic properties, in major depressive disorder. Int J Neuropsychopharmacol 2007;10:661–673.Google ScholarPubMed
Papakostas, GIFava, MDoes the probability of receiving placebo influence clinical trial outcome? A meta-regression of double-blind, randomized clinical trials in MDD. Eur Neuropsychopharmacol 2009;19:34–40.CrossRefGoogle ScholarPubMed
Parrott, ACHindmarch, IThe Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations: a review. Psychopharmacology (Berl) 1980;71:173–179.CrossRefGoogle ScholarPubMed
Posternak, MAZimmerman, MIs there a delay in the antidepressant effect? A meta-analysis. J Clin Psychiatry 2005;66(2):148–158.CrossRefGoogle Scholar
Quitkin, FMRabkin, JDMarkowitz, JMStewart, JWMcGrath, PJHarrison, WUse of pattern analysis to identify true drug response. A replication. Arch Gen Psychiatry 1987;44:259–264.CrossRefGoogle ScholarPubMed
Rosenberg, MSAdams, DCGurevitch, JMeta Win. Statistical software for meta-analysis. Version 2 Sunderland: Massachusetts: Sinauer Associates; 2000.Google Scholar
Rothwell, PMExternal validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet 2005;365:82–93.CrossRefGoogle Scholar
Rush, AJTrivedi, MHIbrahim, HM, et al.The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry 2003;54:573–583.CrossRefGoogle ScholarPubMed
Rush, AJTrivedi, MHWisniewski, SR, et al.Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med 2006;354:1231–1242.CrossRefGoogle ScholarPubMed
Sheehan, DVHarnett-Sheehan, KRaj, BAThe measurement of disability. Int Clin Psychopharmacol 1996;11:89–95.CrossRefGoogle ScholarPubMed
Srinivasan, VDe Berardis, DShillcutt, SDBrzezinski, ARole of melatonin in mood disorders and the antidepressant effects of agomelatine. Expert Opin Investig Drugs 2012;21(10):1503–1522.CrossRefGoogle ScholarPubMed
Stassen, HAngst, JDelini-Stula, AOnset of improvement under fluoxetine and moclobemide. Eur Psychiatry 1998;13:128–133.CrossRefGoogle ScholarPubMed
Stroup, DFBerlin, JAMorton, SCOlkin, IWilliamson, GDRennie, D, et al.Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of observational studies in epidemiology (MOOSE) group. JAMA 2000;283(15):2008e12.CrossRefGoogle ScholarPubMed
Swanson, KABastani, RRubenstein, LVMeredith, LSFord, DEEffect of mental health care and shared decision making on patient satisfaction in a community sample of patients with depression. Med Care Res Rev 2007;64:416–430.CrossRefGoogle Scholar
Szegedi, AJansen, WTvan Willigenburg, APvan der Meulen, EStassen, HHThase, MEEarly 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.CrossRefGoogle ScholarPubMed
Tadić, AHelmreich, IMergl, 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.CrossRefGoogle ScholarPubMed
Tadić, AWagner, SGorbulev, SDahmen, NHiemke, CBraus, D, et al.Peripheral blood and neuropsychological markers for the onset of action of antidepressant drugs in patients with major depressive disorder. BMC Psychiatry 2011;11:16.CrossRefGoogle ScholarPubMed
Thornicroft, GSartorius, NThe course and outcome of depression in different cultures: 10-year follow-up of the WHO Collaborative Study on the Assessment of Depressive Disorders. Psychol Med 1993;23:1023–1032.CrossRefGoogle Scholar
Trivedi, MHRush, AJWisniewski, SR, et al.Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry 2006;163:28–40.CrossRefGoogle ScholarPubMed
van Calker, DZobel, IDykierek, PDeimel, PKech, SLieb, K, 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.CrossRefGoogle ScholarPubMed
Wade, AFriis Andersen, HThe onset of effect for escitalopram and its relevance for the clinical management of depression. Curr Med Res Opin 2006;22:2101–2110.CrossRefGoogle ScholarPubMed
Walsh, BTSeidman, SNSysko, RGould, MPlacebo response in studies of major depression: variable, substantial, and growing. JAMA 2002;287:1840–1847.CrossRefGoogle ScholarPubMed
Winokur, GWhat to do? Or what do we owe our residents?. Biol Psychiatry 1980;15:599–611.Google ScholarPubMed
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