BACKGROUND/RATIONALE:
In the last several years, commercial pharmacogenetic (PGx) testing for psychotropic medications has become widespread as a means of implementing "precision medicine", with some insurers electing to cover the cost of testing. These developments have put increasing pressure on the Veterans Health Administration to implement a mental health focused PGxs program, especially for treating depression, but without sufficient scientific study to support the utility of clinical application.
OBJECTIVE(S):
We propose a program of research to evaluate the utility of PGx testing in treating Major Depressive Disorder.
METHODS:
We plan a multi-site RCT (n=2000), patient/provider dyads will be randomly assigned to receive results of the PGx battery right after randomization (i.e. intervention group) or after 6 months of treatment as usual (i.e. delayed results group)The study will test the following hypotheses:
1.Veterans with MDD whose care is guided by the results of the PGx battery (the intervention group) will have a higher rate of remission of depression than the delayed results group. (Primary Hypothesis)
2.Provider/patient dyads in the intervention group will use fewer contraindicated medications based on established PGx criteria than the delayed results group. (Primary Hypothesis)
The following patient inclusion and exclusion criteria will be used:
Patient Inclusion Criteria. a) age 18 to 80 years, inclusive; b) PHQ-9 score 10 and a presumptive diagnosis of MDD per PHQ-9 criteria; c) at least one prior treatment exposure for MDD (psychotherapy or antidepressant); d) intent to start treatment of the MDD with an antidepressant (simple dose increases will not be considered inclusionary), and e) willingness to provide signed, informed consent to participate in the study.
Patient Exclusion Criteria. a) current serious co-occurring psychiatric illness (i.e., schizophrenia, bipolar disorder, psychotic major depression, borderline or antisocial personality disorder, eating disorder; b) active alcohol or other drug use disorder; c) PTSD checklist (PCL-5) score > 39; d) current use of an antipsychotic medication; e) augmentation therapy, e.g., use of two or more antidepressants at the time of randomization (trazodone at a dosage < 150 mg/day will not be considered augmentation and thus allowed); f) patients requiring urgent care or inpatient hospitalization at the time of consent; or g) currently incarcerated.
FINDINGS/RESULTS:
None at this time, the project is recruiting at this time.
IMPACT:
Despite such a compelling epidemiological imperative, the treatment of depression is often inadequate. As shown now in several studies, to achieve remission from depression, patients and providers must be persistent and try multiple treatments until they find one that is both tolerable and effective. However, with each round of treatment, there is greater attrition from treatment. Replication of the results from the limited PGx implementation studies that have been conducted to date could usher in a new era in the treatment of MDD and provide an impetus for early diagnosis and treatment, resulting in more rapid and higher rates of remission. No change in the impact.
External Links for this Project
PUBLICATIONS:
Journal Articles
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- Dalvie S, Maihofer AX, Coleman JRI, Bradley B, Breen G, Brick LA, Chen CY, Choi KW, Duncan LE, Guffanti G, Haas M, Harnal S, Liberzon I, Nugent NR, Provost AC, Ressler KJ, Torres K, Amstadter AB, Bryn Austin S, Baker DG, Bolger EA, Bryant RA, Calabrese JR, Delahanty DL, Farrer LA, Feeny NC, Flory JD, Forbes D, Galea S, Gautam A, Gelernter J, Hammamieh R, Jett M, Junglen AG, Kaufman ML, Kessler RC, Khan A, Kranzler HR, Lebois LAM, Marmar C, Mavissakalian MR, McFarlane A, Donnell MO, Orcutt HK, Pietrzak RH, Risbrough VB, Roberts AL, Rothbaum AO, Roy-Byrne P, Ruggiero K, Seligowski AV, Sheerin CM, Silove D, Smoller JW, Stein MB, Teicher MH, Ursano RJ, Van Hooff M, Winternitz S, Wolff JD, Yehuda R, Zhao H, Zoellner LA, Stein DJ, Koenen KC, Nievergelt CM. Genomic influences on self-reported childhood maltreatment. Translational psychiatry. 2020 Jan 27; 10(1):38. [view]
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- Hartwell EE, Feinn R, Morris PE, Gelernter J, Krystal J, Arias AJ, Hoffman M, Petrakis I, Gueorguieva R, Schacht JP, Oslin D, Anton RF, Kranzler HR. Systematic review and meta-analysis of the moderating effect of rs1799971 in OPRM1, the mu-opioid receptor gene, on response to naltrexone treatment of alcohol use disorder. Addiction (Abingdon, England). 2020 Aug 1; 115(8):1426-1437. [view]
- van der Markt A, Klumpers UM, Draisma S, Dols A, Nolen WA, Post RM, Altshuler LL, Frye MA, Grunze H, Keck PE, McElroy SL, Suppes T, Beekman AT, Kupka RW. Testing a clinical staging model for bipolar disorder using longitudinal life chart data. Bipolar disorders. 2019 May 1; 21(3):228-234. [view]
- de Zwarte SMC, Brouwer RM, Agartz I, Alda M, Aleman A, Alpert KI, Bearden CE, Bertolino A, Bois C, Bonvino A, Bramon E, Buimer EEL, Cahn W, Cannon DM, Cannon TD, Caseras X, Castro-Fornieles J, Chen Q, Chung Y, De la Serna E, Di Giorgio A, Doucet GE, Eker MC, Erk S, Fears SC, Foley SF, Frangou S, Frankland A, Fullerton JM, Glahn DC, Goghari VM, Goldman AL, Gonul AS, Gruber O, de Haan L, Hajek T, Hawkins EL, Heinz A, Hillegers MHJ, Hulshoff Pol HE, Hultman CM, Ingvar M, Johansson V, Jönsson EG, Kane F, Kempton MJ, Koenis MMG, Kopecek M, Krabbendam L, Krämer B, Lawrie SM, Lenroot RK, Marcelis M, Marsman JC, Mattay VS, McDonald C, Meyer-Lindenberg A, Michielse S, Mitchell PB, Moreno D, Murray RM, Mwangi B, Najt P, Neilson E, Newport J, van Os J, Overs B, Ozerdem A, Picchioni MM, Richter A, Roberts G, Aydogan AS, Schofield PR, Simsek F, Soares JC, Sugranyes G, Toulopoulou T, Tronchin G, Walter H, Wang L, Weinberger DR, Whalley HC, Yalin N, Andreassen OA, Ching CRK, van Erp TGM, Turner JA, Jahanshad N, Thompson PM, Kahn RS, van Haren NEM. The Association Between Familial Risk and Brain Abnormalities Is Disease Specific: An ENIGMA-Relatives Study of Schizophrenia and Bipolar Disorder. Biological psychiatry. 2019 Oct 1; 86(7):545-556. [view]
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- Gonzalez R, Gonzalez SD, Mallawaarachchic I, Suppes P. The relationship between circadian gene single nucleotide polymorphisms and clinical and behavioral assessments of sleep and rhythms and course of illness characteristics in subjects with bipolar type I disorder. Personalized medicine. 2019 Feb 12; 2019(13-14):11-18. [view]
- Hidalgo-Mazzei D, Berk M, Cipriani A, Cleare AJ, Florio AD, Dietch D, Geddes JR, Goodwin GM, Grunze H, Hayes JF, Jones I, Kasper S, Macritchie K, McAllister-Williams RH, Morriss R, Nayrouz S, Pappa S, Soares JC, Smith DJ, Suppes T, Talbot P, Vieta E, Watson S, Yatham LN, Young AH, Stokes PRA. Treatment-resistant and multi-therapy-resistant criteria for bipolar depression: consensus definition. The British journal of psychiatry : the journal of mental science. 2019 Jan 1; 214(1):27-35. [view]
- de Araújo CM, Hudziak J, Crocetti D, Wymbs NF, Montalvo-Ortiz JL, Orr C, Albaugh MD, Althoff RR, O'Loughlin K, Holbrook H, Garavan H, Yang BZ, Mostofsky S, Jackowski A, Lee RS, Gelernter J, Kaufman J. Tubulin Polymerization Promoting Protein (TPPP) gene methylation and corpus callosum measures in maltreated children. Psychiatry research. Neuroimaging. 2020 Apr 30; 298:111058. [view]
- Hull LE, Lynch KG, Oslin DW. VA Primary Care and Mental Health Providers' Comfort with Genetic Testing: Survey Results from the PRIME Care Study. Journal of general internal medicine. 2019 Jun 1; 34(6):799-801. [view]
Journal Other
- Vieta E, Berk M, Schulze TG, Carvalho AF, Suppes T, Calabrese JR, Gao K, Miskowiak KW, Grande I. Bipolar disorders. [Book Review]. Nature reviews. Disease primers. 2018 Mar 8; 4:18008. [view]
- Zhou H, Sealock JM, Sanchez-Roige S, Clarke TK, Levey DF, Cheng Z, Li B, Polimanti R, Kember RL, Smith RV, Thygesen JH, Morgan MY, Atkinson SR, Thursz MR, Nyegaard M, Mattheisen M, Børglum AD, Johnson EC, Justice AC, Palmer AA, McQuillin A, Davis LK, Edenberg HJ, Agrawal A, Kranzler HR, Gelernter J. Genome-wide meta-analysis of problematic alcohol use in 435,563 individuals yields insights into biology and relationships with other traits. [Abstract]. Nature neuroscience. 2020 Jul 1; 23(7):809-818. [view]
DRA:
Mental, Cognitive and Behavioral Disorders, Substance Use Disorders
DRE:
Genomics, Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational
Keywords:
Substance Use and Abuse
MeSH Terms:
none
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