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.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Kramer NE, Cosgrove VE, Dunlap K, Subramaniapillai M, McIntyre RS, Suppes T. A clinical model for identifying an inflammatory phenotype in mood disorders. Journal of psychiatric research. 2019 Jun 1; 113:148-158. [view]
2. Imran TF, Posner D, Honerlaw J, Vassy JL, Song RJ, Ho YL, Kittner SJ, Liao KP, Cai T, O'Donnell CJ, Djousse L, Gagnon DR, Gaziano JM, Wilson PW, Cho K. A phenotyping algorithm to identify acute ischemic stroke accurately from a national biobank: the Million Veteran Program. Clinical epidemiology. 2018 Oct 16; 10:1509-1521. [view]
3. Cheng Z, Phokaew C, Chou YL, Lai D, Meyers JL, Agrawal A, Farrer LA, Kranzler HR, Gelernter J. A regulatory variant of CHRM3 is associated with cannabis-induced hallucinations in European Americans. Translational psychiatry. 2019 Nov 18; 9(1):309. [view]
4. Leroux AJ, Waid-Ebbs JK, Wen PS, Helmer DA, Graham DP, O'Connor MK, Ray K. An Investigation of Exposure Control Methods With Variable-Length CAT Using the Partial Credit Model. Applied psychological measurement. 2019 Nov 1; 43(8):624-638. [view]
5. Nielsen DA, Spellicy CJ, Harding MJ, Graham DP. Apolipoprotein E DNA methylation and posttraumatic stress disorder are associated with plasma ApoE level: A preliminary study. Behavioural brain research. 2019 Jan 1; 356:415-422. [view]
6. Verma A, Huffman JE, Gao L, Minnier J, Wu WC, Cho K, Ho YL, Gorman BR, Pyarajan S, Rajeevan N, Garcon H, Joseph J, McGeary JE, Suzuki A, Reaven PD, Wan ES, Lynch JA, Petersen JM, Meigs JB, Freiberg MS, Gatsby E, Lynch KE, Zekavat SM, Natarajan P, Dalal S, Jhala DN, Arjomandi M, Bonomo RA, Thompson TK, Pathak GA, Zhou JJ, Donskey CJ, Madduri RK, Wells QS, Gelernter J, Huang RDL, Polimanti R, Chang KM, Liao KP, Tsao PS, Sun YV, Wilson PWF, O'Donnell CJ, Hung AM, Gaziano JM, Hauger RL, Iyengar SK, Luoh SW, VA Million Veteran Program COVID-19 Science Initiative. Association of Kidney Comorbidities and Acute Kidney Failure With Unfavorable Outcomes After COVID-19 in Individuals With the Sickle Cell Trait. JAMA internal medicine. 2022 Aug 1; 182(8):796-804. [view]
7. Zhou H, Rentsch CT, Cheng Z, Kember RL, Nunez YZ, Sherva RM, Tate JP, Dao C, Xu K, Polimanti R, Farrer LA, Justice AC, Kranzler HR, Gelernter J, Veterans Affairs Million Veteran Program. Association of OPRM1 Functional Coding Variant With Opioid Use Disorder: A Genome-Wide Association Study. JAMA psychiatry. 2020 Oct 1; 77(10):1072-1080. [view]
8. Na PJ, Montalvo-Ortiz JL, Nagamatsu ST, Southwick SM, Krystal JH, Gelernter J, Pietrzak RH. Association of Symptoms of Posttraumatic Stress Disorder and GrimAge, an Epigenetic Marker of Mortality Risk, in US Military Veterans. The Journal of clinical psychiatry. 2022 Jul 6; 83(4). [view]
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10. Yatham LN, Kennedy SH, Parikh SV, Schaffer A, Bond DJ, Frey BN, Sharma V, Goldstein BI, Rej S, Beaulieu S, Alda M, MacQueen G, Milev RV, Ravindran A, O'Donovan C, McIntosh D, Lam RW, Vazquez G, Kapczinski F, McIntyre RS, Kozicky J, Kanba S, Lafer B, Suppes T, Calabrese JR, Vieta E, Malhi G, Post RM, Berk M. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder. Bipolar disorders. 2018 Mar 14; 20(2):97-170. [view]
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12. Ziobrowski HN, Cui R, Ross EL, Liu H, Puac-Polanco V, Turner B, Leung LB, Bossarte RM, Bryant C, Pigeon WR, Oslin DW, Post EP, Zaslavsky AM, Zubizarreta JR, Nierenberg AA, Luedtke A, Kennedy CJ, Kessler RC. Development of a model to predict psychotherapy response for depression among Veterans. Psychological medicine. 2023 Jun 1; 53(8):3591-3600. [view]
13. Raghavan S, Vassy JL, Ho YL, Song RJ, Gagnon DR, Cho K, Wilson PWF, Phillips LS. Diabetes Mellitus-Related All-Cause and Cardiovascular Mortality in a National Cohort of Adults. Journal of the American Heart Association. 2019 Feb 19; 8(4):e011295. [view]
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15. Hull LE, Chanfreau-Coffinier C, Tuteja S, Berlowitz D, Lehmann LS, Oslin DW, Pyne JM, DuVall SL, Lynch JA. Early adoption of pharmacogenetic testing for veterans prescribed psychotropic medications. Pharmacogenomics. 2019 Jul 1; 20(11):781-789. [view]
16. Oslin DW, Lynch KG, Shih MC, Ingram EP, Wray LO, Chapman SR, Kranzler HR, Gelernter J, Pyne JM, Stone A, DuVall SL, Lehmann LS, Thase ME, PRIME Care Research Group , Aslam M, Batki SL, Bjork JM, Blow FC, Brenner LA, Chen P, Desai S, Dieperink EW, Fears SC, Fuller MA, Goodman CS, Graham DP, Haas GL, Hamner MB, Helstrom AW, Hurley RA, Icardi MS, Jurjus GJ, Kilbourne AM, Kreyenbuhl J, Lache DJ, Lieske SP, Lynch JA, Meyer LJ, Montalvo C, Muralidhar S, Ostacher MJ, Paschall GY, Pfeiffer PN, Prieto S, Przygodzki RM, Ranganathan M, Rodriguez-Suarez MM, Roggenkamp H, Schichman SA, Schneeweis JS, Simonetti JA, Steinhauer SR, Suppes T, Umbert MA, Vassy JL, Voora D, Wiechers IR, Wood AE. Effect of Pharmacogenomic Testing for Drug-Gene Interactions on Medication Selection and Remission of Symptoms in Major Depressive Disorder: The PRIME Care Randomized Clinical Trial. JAMA. 2022 Jul 12; 328(2):151-161. [view]
17. McIntyre RS, Subramaniapillai M, Lee Y, Pan Z, Carmona NE, Shekotikhina M, Rosenblat JD, Brietzke E, Soczynska JK, Cosgrove VE, Miller S, Fischer EG, Kramer NE, Dunlap K, Suppes T, Mansur RB. Efficacy of Adjunctive Infliximab vs Placebo in the Treatment of Adults With Bipolar I/II Depression: A Randomized Clinical Trial. JAMA psychiatry. 2019 Aug 1; 76(8):783-790. [view]
18. Montalvo-Ortiz JL, Gelernter J, Cheng Z, Girgenti MJ, Xu K, Zhang X, Gopalan S, Zhou H, Duman RS, Southwick SM, Krystal JH, Traumatic Stress Brain Research Study Group, Pietrzak RH. Epigenome-wide association study of posttraumatic stress disorder identifies novel loci in U.S. military veterans. Translational psychiatry. 2022 Feb 17; 12(1):65. [view]
19. Vreeker A, Fears SC, Service SK, Pagani L, Takahashi JS, Araya C, Araya X, Bejarano J, Lopez MC, Montoya G, Montoya CP, Teshiba TM, Escobar J, Cantor RM, López-Jaramillo C, Macaya G, Molina J, Reus VI, Sabatti C, Ophoff RA, Freimer NB, Bearden CE. Genetic analysis of activity, brain and behavioral associations in extended families with heavy genetic loading for bipolar disorder. Psychological medicine. 2021 Feb 1; 51(3):494-502. [view]
20. Stein MB, Chen CY, Jain S, Jensen KP, He F, Heeringa SG, Kessler RC, Maihofer A, Nock MK, Ripke S, Sun X, Thomas ML, Ursano RJ, Smoller JW, Gelernter J, Army STARRS Collaborators. Genetic risk variants for social anxiety. American journal of medical genetics. Part B, Neuropsychiatric genetics : the official publication of the International Society of Psychiatric Genetics. 2017 Jun 1; 174(4):470-482. [view]
21. Stein MB, Chen CY, Jain S, Jensen KP, He F, Heeringa SG, Kessler RC, Maihofer A, Nock MK, Ripke S, Sun X, Thomas ML, Ursano RJ, Smoller JW, Gelernter J, Army STARRS Collaborators. Genetic risk variants for social anxiety. American journal of medical genetics. Part B, Neuropsychiatric genetics : the official publication of the International Society of Psychiatric Genetics. 2017 Mar 1; 174(2):120-131. [view]
22. Lippard ETC, Jensen KP, Wang F, Johnston JAY, Spencer L, Pittman B, Gelernter J, Blumberg HP. Genetic variation of ANK3 is associated with lower white matter structural integrity in bipolar disorder. Molecular Psychiatry. 2017 Sep 1; 22(9):1225. [view]
23. Sun Y, Chang S, Wang F, Sun H, Ni Z, Yue W, Zhou H, Gelernter J, Malison RT, Kalayasiri R, Wu P, Lu L, Shi J. Genome-wide association study of alcohol dependence in male Han Chinese and cross-ethnic polygenic risk score comparison. Translational psychiatry. 2019 Oct 7; 9(1):249. [view]
24. Polimanti R, Zhang H, Smith AH, Zhao H, Farrer LA, Kranzler HR, Gelernter J. Genome-wide association study of body mass index in subjects with alcohol dependence. Addiction Biology. 2017 Mar 1; 22(2):535-549. [view]
25. Cox JW, Sherva RM, Lunetta KL, Johnson EC, Martin NG, Degenhardt L, Agrawal A, Nelson EC, Kranzler HR, Gelernter J, Farrer LA. Genome-Wide Association Study of Opioid Cessation. Journal of clinical medicine. 2020 Jan 9; 9(1). [view]
26. Hettema JM, Verhulst B, Chatzinakos C, Bacanu SA, Chen CY, Ursano RJ, Kessler RC, Gelernter J, Smoller JW, He F, Jain S, Stein MB. Genome-wide association study of shared liability to anxiety disorders in Army STARRS. American journal of medical genetics. Part B, Neuropsychiatric genetics : the official publication of the International Society of Psychiatric Genetics. 2020 Jun 1; 183(4):197-207. [view]
27. 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]
28. Hunter-Zinck H, Shi Y, Li M, Gorman BR, Ji SG, Sun N, Webster T, Liem A, Hsieh P, Devineni P, Karnam P, Gong X, Radhakrishnan L, Schmidt J, Assimes TL, Huang J, Pan C, Humphries D, Brophy M, Moser J, Muralidhar S, Huang GD, Przygodzki R, Concato J, Gaziano JM, Gelernter J, O'Donnell CJ, Hauser ER, Zhao H, O'Leary TJ, VA Million Veteran Program, Tsao PS, Pyarajan S. Genotyping Array Design and Data Quality Control in the Million Veteran Program. American Journal of Human Genetics. 2020 Apr 2; 106(4):535-548. [view]
29. Nievergelt CM, Maihofer AX, Klengel T, Atkinson EG, Chen CY, Choi KW, Coleman JRI, Dalvie S, Duncan LE, Gelernter J, Levey DF, Logue MW, Polimanti R, Provost AC, Ratanatharathorn A, Stein MB, Torres K, Aiello AE, Almli LM, Amstadter AB, Andersen SB, Andreassen OA, Arbisi PA, Ashley-Koch AE, Austin SB, Avdibegovic E, Babic D, Bækvad-Hansen M, Baker DG, Beckham JC, Bierut LJ, Bisson JI, Boks MP, Bolger EA, Børglum AD, Bradley B, Brashear M, Breen G, Bryant RA, Bustamante AC, Bybjerg-Grauholm J, Calabrese JR, Caldas-de-Almeida JM, Dale AM, Daly MJ, Daskalakis NP, Deckert J, Delahanty DL, Dennis MF, Disner SG, Domschke K, Dzubur-Kulenovic A, Erbes CR, Evans A, Farrer LA, Feeny NC, Flory JD, Forbes D, Franz CE, Galea S, Garrett ME, Gelaye B, Geuze E, Gillespie C, Uka AG, Gordon SD, Guffanti G, Hammamieh R, Harnal S, Hauser MA, Heath AC, Hemmings SMJ, Hougaard DM, Jakovljevic M, Jett M, Johnson EO, Jones I, Jovanovic T, Qin XJ, Junglen AG, Karstoft KI, Kaufman ML, Kessler RC, Khan A, Kimbrel NA, King AP, Koen N, Kranzler HR, Kremen WS, Lawford BR, Lebois LAM, Lewis CE, Linnstaedt SD, Lori A, Lugonja B, Luykx JJ, Lyons MJ, Maples-Keller J, Marmar C, Martin AR, Martin NG, Maurer D, Mavissakalian MR, McFarlane A, McGlinchey RE, McLaughlin KA, McLean SA, McLeay S, Mehta D, Milberg WP, Miller MW, Morey RA, Morris CP, Mors O, Mortensen PB, Neale BM, Nelson EC, Nordentoft M, Norman SB, O'Donnell M, Orcutt HK, Panizzon MS, Peters ES, Peterson AL, Peverill M, Pietrzak RH, Polusny MA, Rice JP, Ripke S, Risbrough VB, Roberts AL, Rothbaum AO, Rothbaum BO, Roy-Byrne P, Ruggiero K, Rung A, Rutten BPF, Saccone NL, Sanchez SE, Schijven D, Seedat S, Seligowski AV, Seng JS, Sheerin CM, Silove D, Smith AK, Smoller JW, Sponheim SR, Stein DJ, Stevens JS, Sumner JA, Teicher MH, Thompson WK, Trapido E, Uddin M, Ursano RJ, van den Heuvel LL, Van Hooff M, Vermetten E, Vinkers CH, Voisey J, Wang Y, Wang Z, Werge T, Williams MA, Williamson DE, Winternitz S, Wolf C, Wolf EJ, Wolff JD, Yehuda R, Young RM, Young KA, Zhao H, Zoellner LA, Liberzon I, Ressler KJ, Haas M, Koenen KC. International meta-analysis of PTSD genome-wide association studies identifies sex- and ancestry-specific genetic risk loci. Nature communications. 2019 Oct 8; 10(1):4558. [view]
30. Polimanti R, Walters RK, Johnson EC, McClintick JN, Adkins AE, Adkins DE, Bacanu SA, Bierut LJ, Bigdeli TB, Brown S, Bucholz KK, Copeland WE, Costello EJ, Degenhardt L, Farrer LA, Foroud TM, Fox L, Goate AM, Grucza R, Hack LM, Hancock DB, Hartz SM, Heath AC, Hewitt JK, Hopfer CJ, Johnson EO, Kendler KS, Kranzler HR, Krauter K, Lai D, Madden PAF, Martin NG, Maes HH, Nelson EC, Peterson RE, Porjesz B, Riley BP, Saccone N, Stallings M, Wall TL, Webb BT, Wetherill L, Psychiatric Genomics Consortium Substance Use Disorders Workgroup, Edenberg HJ, Agrawal A, Gelernter J. Leveraging genome-wide data to investigate differences between opioid use vs. opioid dependence in 41,176 individuals from the Psychiatric Genomics Consortium. Molecular Psychiatry. 2020 Aug 1; 25(8):1673-1687. [view]
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Journal Other

1. 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]
2. 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: Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational, Genomics
Keywords: Substance Use and Abuse
MeSH Terms: none