Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: Results of a randomized, double-blind clinical trial

BMC Psychiatry

Volumn 17, Issue 1, 2017, Pages

  Pérez, Víctor ^a,b   Salavert, Ariana ^c   Espadaler, Jordi ^c   Tuson, Miquel ^c   Saiz Ruiz, Jerónimo ^a,d   Sáez Navarro, Cristina ^a,e   Bobes, Julio ^a,f   Baca García, Enrique ^a,g,h,i   Vieta, Eduard ^a,j   Olivares, José M ^k   Rodriguez Jimenez, Roberto ^a,l   Villagrán, José M ^m   Gascón, Josep ⁿ   Cañete Crespillo, Josep ^o   Solé, Montse ^a,e   Saiz, Pilar A ^a,f   Ibáñez, Ángela ^a,d   de Diego Adeliño, Javier ^a,b   Menchón, José M ^a,j,p   álvarez, Enric ^a,o   Garriga, Marina ^a,o   Castaño, Juan ^a,o   Díez Aja, Cristobal ^a,o   Sánchez González, Roberto ^a,o   Bagney, Alexandra ^a,o   García Portilla, María Paz ^a,o   Bauzà, Joana ^a,o   Bernardo, Miquel ^a,o   Rodao, José M ^a,o   Merce Brat ^a,o   Mongil, José M ^l   Garrido, Juan Miguel ^a   Holgado, Pedro M ^b,k   Aguilar, Eva ^f,q   Safont, Gemma ^m   Martín del Moral, Mercedes ^k   Quintero, Javier ^j   Mora, Fernando ^j   Barrigón, María Luisa ^g,i   Villoria, Lucía ^g,i   Soria, Virginia ^a,b,d   Blanch, Jordi ^a,b   Rissech, Núria ^c   Puigmulé, Marta ^c   Bonachera, Miquel Àngel ^c   Mayoral Cleries, Fermín ^p   Cantero, Nazaret ^p   Palao, Diego J ^q   Irastorza, Luis Javier ^r   Navarro, Rafael ^b   more..

^a CENTRO DE INVESTIGACIÓN BIOMÉDICA EN RED DE SALUD MENTAL CIBERSAM   (Spain)

^b UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^c AB BIOTICS SA   (Spain)

^d HOSPITAL RAMÓN Y CAJAL   (Spain)

^e UNIVERSITAT ROVIRA I VIRGILI   (Spain)

^f UNIVERSITY OF OVIEDO   (Spain)

^g Instituto de Investigación Sanitaria Fundación Jiménez Díaz   (Spain)

^h UNIVERSIDAD AUTÓNOMA DE MADRID   (Spain)

ⁱ Howard Hughes Medical Institute   (United States)

^j UNIVERSITY OF BARCELONA   (Spain)

^k UNIVERSITY HOSPITAL COMPLEX OF VIGO   (Spain)

^l Psychiatric Hospitalization Unit ^*  (Spain)

^m HOSPITAL DE JEREZ   (Spain)

ⁿ HOSPITAL MÚTUA DE TERRASSA   (Spain)

^o HOSPITAL DE MATARÓ   (Spain)

^p HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^q HOSPITAL REGIONAL UNIVERSITARIO DE MÁLAGA   (Spain)

^r HOSPITAL UNIVERSITARIO INFANTA LEONOR   (Spain)

more..

Author keywords

Antidepressant response; Depression; Pharmacogenetics; Precision medicine; Randomized clinical trial

Indexed keywords

ANTIDEPRESSANT AGENT;

ADULT; ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; COMPUTER ANALYSIS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG INDICATION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; GENETIC SCREENING; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MULTICENTER STUDY; PARALLEL DESIGN; PHARMACOGENETICS; PSYCHIATRIST; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT RESPONSE; CLINICAL TRIAL; GENETICS; MIDDLE AGED; PHARMACOGENETIC TESTING; TREATMENT OUTCOME;

ADULT; ANTIDEPRESSIVE AGENTS; DEPRESSIVE DISORDER, MAJOR; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PHARMACOGENOMIC TESTING; TREATMENT OUTCOME;

EID: 85023741208     PISSN: None     EISSN: 1471244X     Source Type: Journal    
DOI: 10.1186/s12888-017-1412-1     Document Type: Article

References (44)

1. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden Of Disease Study 2010. Lancet. 2012;380(9859):2163-96.
2. Crisafulli C, Fabbri C, Porcelli S, Drago A, Spina E, De Ronchi D, Serretti A. Pharmacogenetics of antidepressants. Front Pharmacol. 2011;2:6.
3. Kelly K, Posternak M, Alpert JE. Toward achieving optimal response: understanding and managing antidepressant side effects. Dialogues Clin Neurosci. 2008;10(4):409-18.
4. Tansey KE, Guipponi M, Hu X, Domenici E, Lewis G, Malafosse A, Wendland JR, Lewis CM, McGuffin P, Uher R. Contribution of common genetic variants to antidepressant response. Biol Psychiatry. 2013;73(7):679-82.
5. Perlis RH. Pharmacogenomic testing and personalized treatment of depression. Clin Chem. 2014;60(1):53-9.
6. Bousman CA, Hopwood M. Commercial pharmacogenetic-based decision-support tools in psychiatry. Lancet Psychiatry. 2016;3(6):585-90.
7. Altar CA, Hornberger J, Shewade A, Cruz V, Garrison J, Mrazek D. Clinical validity of cytochrome P450 metabolism and serotonin gene variants in psychiatric pharmacotherapy. Int Rev Psychiatry. 2013;25(5):509-33.
8. Fabbri C, Serretti A. Pharmacogenetics of major depressive disorder: top genes and pathways toward clinical applications. Curr Psychiatry Rep. 2015;17(7):50.
9. Breitenstein B, Scheuer S, Pfister H, Uhr M, Lucae S, Holsboer F, Ising M, Bruckl TM. The clinical application of ABCB1 genotyping in antidepressant treatment: a pilot study. CNS Spectr. 2014;19(2):165-75.
10. Outhred T, Das P, Dobson-Stone C, Felmingham KL, Bryant RA, Nathan PJ, Malhi GS, Kemp AH. Impact of 5-HTTLPR on SSRI serotonin transporter blockade during emotion regulation: a preliminary fMRI study. J Affect Disord. 2016;196:11-9.
11. Hicks JK, Sangkuhl K, Swen JJ, Ellingrod VL, Muller DJ, Shimoda K, Bishop JR, Kharasch ED, Skaar TC, Gaedigk A, et al. Clinical pharmacogenetics implementation consortium guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants: 2016 update. Clin Pharmacol Ther. 2016. [Epub ahead of print].
12. Hicks JK, Bishop JR, Sangkuhl K, Muller DJ, Ji Y, Leckband SG, Leeder JS, Graham RL, Chiulli DL, LLerena A, et al. Clinical Pharmacogenetics implementation consortium (CPIC) guideline for CYP2D6 and CYP2C19 genotypes and dosing of selective serotonin reuptake inhibitors. Clin Pharmacol Ther. 2015;98(2):127-34.
13. Drozda K, Muller DJ, Bishop JR. Pharmacogenomic testing for neuropsychiatric drugs: current status of drug labeling, guidelines for using genetic information, and test options. Pharmacotherapy. 2014;34(2):166-84.
14. Ehmann F, Caneva L, Prasad K, Paulmichl M, Maliepaard M, Llerena A, Ingelman-Sundberg M, Papaluca-Amati M. Pharmacogenomic information in drug labels: European Medicines agency perspective. pharmacogenomics J. 2015;15(3):201-10.
15. Vieta E. Personalised medicine applied to mental health: precision psychiatry. Rev Psiquiatr Salud Ment. 2015;8(3):117-8.
16. Jurgens G, Jacobsen CB, Rasmussen HB, Werge T, Nordentoft M, Andersen SE. Utility and adoption of CYP2D6 and CYP2C19 genotyping and its translation into psychiatric clinical practice. Acta Psychiatr Scand. 2012;125(3):228-37.
17. Rosenblat JD, Lee Y, McIntyre RS. Does Pharmacogenomic testing improve clinical outcomes for major depressive disorder? A systematic review of clinical trials and cost-effectiveness studies. J Clin Psychiatry. 2017;78(6):720-29.
18. Winner JG, Carhart JM, Altar CA, Allen JD, Dechairo BM. A prospective, randomized, double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder. Discov Med. 2013;16(89):219-27.
19. Singh AB. Improved antidepressant remission in major depression via a pharmacokinetic pathway polygene Pharmacogenetic report. Clin Psychopharmacol Neurosci. 2015;13(2):150-6.
20. Espadaler J, Tuson M, Lopez-Ibor JM, Lopez-Ibor F, Lopez-Ibor MI: Pharmacogenetic testing for the guidance of psychiatric treatment: a multicenter retrospective analysis. CNS Spectr. 2016;1-10. [Epub ahead of print].
21. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.
22. Guy W. Clinical global impression scale. The ECDEU Assessment Manual for Psychopharmacology-Revised Volume DHEW Publ No ADM 76. 1976;338:218-22.
23. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23(1):56.
24. Wisniewski SR, Rush AJ, Balasubramani GK, Trivedi MH, Nierenberg AA. Self-rated global measure of the frequency, intensity, and burden of side effects. J Psychiatr Pract. 2006;12(2):71-9.
25. Sheehan D, Harnett-Sheehan K, Raj B. The measurement of disability. Int Clin Psychopharmacol. 1996;11:89-95.
26. Bobes J, Badia X, Luque A, Garcia M, Gonzalez M, Dal-Re R. Validation of the Spanish version of the Liebowitz social anxiety scale, social anxiety and distress scale and Sheehan disability inventory for the evaluation of social phobia. Med Clin. 1999;112(14):530-8.
27. Ruiz MA, Pardo A, Rejas J, Soto J, Villasante F, Aranguren JL. Development and validation of the "Treatment Satisfaction with Medicines Questionnaire" (SATMED-Q). Value Health. 2008;11(5):913-26.
28. Swen JJ, Nijenhuis M, de Boer A, Grandia L, Maitland-van der Zee AH, Mulder H, Rongen GA, van Schaik RH, Schalekamp T, Touw DJ, et al. Pharmacogenetics: from bench to byte--an update of guidelines. Clin Pharmacol Ther. 2011;89(5):662-73.
29. Porcelli S, Fabbri C, Serretti A. Meta-analysis of serotonin transporter gene promoter polymorphism (5-HTTLPR) association with antidepressant efficacy. Eur Neuropsychopharmacol. 2012;22(4):239-58.
30. Niitsu T, Fabbri C, Bentini F, Serretti A. Pharmacogenetics in major depression: a comprehensive meta-analysis. Prog Neuro-Psychopharmacol Biol Psychiatry. 2013;45C:183-94.
31. Breitenstein B, Scheuer S, Bruckl TM, Meyer J, Ising M, Uhr M, Holsboer F. Association of ABCB1 gene variants, plasma antidepressant concentration, and treatment response: results from a randomized clinical study. J Psychiatr Res. 2016;73:86-95.
32. Uhr M, Tontsch A, Namendorf C, Ripke S, Lucae S, Ising M, Dose T, Ebinger M, Rosenhagen M, Kohli M, et al. Polymorphisms in the drug transporter gene ABCB1 predict antidepressant treatment response in depression. Neuron. 2008;57(2):203-9.
33. Kawaguchi DM, Glatt SJ. GRIK4 polymorphism and its association with antidepressant response in depressed patients: a meta-analysis. Pharmacogenomics. 2014;15(11):1451-9.
34. van der Weide K, van der Weide J. The influence of the CYP3A4*22 polymorphism on serum concentration of quetiapine in psychiatric patients. J Clin Psychopharmacol. 2014;34(2):256-60.
35. Mas S, Gasso P, Ritter MA, Malagelada C, Bernardo M, Lafuente A. Pharmacogenetic predictor of extrapyramidal symptoms induced by antipsychotics: Multilocus interaction in the mTOR pathway. Eur Neuropsychopharmacol. 2015;25(1):51-9.
36. Sankoh AJ, Huque MF, Dubey SD. Some comments on frequently used multiple endpoint adjustment methods in clinical trials. Stat Med. 1997;16(22):2529-42.
37. Hedges LV. Distribution theory for Glass's estimator of effect size and related estimators. J Educ Behav Stat. 1981;6(2):107-28.
38. Charland SL, Agatep BC, Herrera V, Schrader B, Frueh FW, Ryvkin M, Shabbeer J, Devlin JJ, Superko HR, Stanek EJ. Providing patients with pharmacogenetic test results affects adherence to statin therapy: results of the additional KIF6 risk offers better adherence to Statins (AKROBATS) trial. Pharmacogenomics J. 2014;14(3):272-80.
39. Wisniewski SR, Rush AJ, Nierenberg AA, Gaynes BN, Warden D, Luther JF, McGrath PJ, Lavori PW, Thase ME, Fava M, et al. Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report. Am J Psychiatry. 2009;166(5):599-607.
40. Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, Fawcett J. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010;303(1):47-53.
41. Rush AJ, Fava M, Wisniewski SR, Lavori PW, Trivedi MH, Sackeim HA, Thase ME, Nierenberg AA, Quitkin FM, Kashner TM, et al. Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design. Control Clin Trials. 2004;25(1):119-42.
42. Hall-Flavin DK, Winner JG, Allen JD, Carhart JM, Proctor B, Snyder KA, Drews MS, Eisterhold LL, Geske J, Mrazek DA. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenet Genomics. 2013;23(10):535-48.
43. Altar CA, Carhart JM, Allen JD, Hall-Flavin DK, Dechairo BM, Winner JG. Clinical validity: combinatorial pharmacogenomics predicts antidepressant responses and healthcare utilizations better than single gene phenotypes. Pharmacogenomics J. 2015;15(5):443-51.
44. Dzau VJ, Ginsburg GS. Realizing the full potential of precision medicine in health and health care. JAMA. 2016;316(16):1659-60.