Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial.
Pharmacogenetic testing holds promise as a personalized medicine tool by permitting individualization of pharmacotherapy in accordance with genes influencing therapeutic response, side effects, and adverse events. The authors evaluated the effect on outcomes for patients diagnosed with neuropsychiatric disorders of pharmacogenetics (PGx)-guided treatment compared to usual standard of care.



This was a prospective, randomized study of 237 patients at an outpatient community-based psychiatric practice conducted between April 2015 and October 2015. Baseline patient assessments and a buccal swab were collected for pharmacogenetic testing at study initiation. For the experimental group, PGx results were provided to the clinicians as guides to treatment. Control subjects were treated according to the usual standard of care with no clinician reference to their PGx results. Neuropsychiatric Questionnaire (NPQ) and Symbol Digit Coding Test (SDC) scores and adverse drug events, hospitalizations, and medication information were collected at 30, 60, and 90 days.



More than half (53%) of patients in the control group reported at least 1 adverse drug event compared to 28% of patients with PGx-guided medication management (P = .001). NPQ and SDC scores improved for both groups, but no statistical difference in efficacy as measured by these assessments was observed within the 90-day observation period.



Pharmacogenetic testing may facilitate psychiatric drug therapy with greater tolerability and similar efficacy compared to standard of care.



ClinicalTrials.gov Identifier: NCT02411123​​.
AltheaDx, 10578 Science Center Dr, San Diego, CA 92121. molson@altheadx.com.|AltheaDx, San Diego, California, USA.
Marilyn C
MC
Olson
AltheaDx, San Diego, California, USA.
Alejandra
A
Maciel
Carolina Partners in Mental Health Care, Raleigh, North Carolina, USA.
Jean Francois
JF
Gariepy
AltheaDx, San Diego, California, USA.
Ali
A
Cullors
InovaGen, Rancho Santa Fe, California, USA.
Juan-Sebastian
JS
Saldivar
AltheaDx, San Diego, California, USA.
David
D
Taylor
AltheaDx, San Diego, California, USA.
Joel
J
Centeno
AltheaDx, San Diego, California, USA.
Jorge A
JA
Garces
Carolina Partners in Mental Health Care, Raleigh, North Carolina, USA.|Departments of Psychiatry and Community and Family Medicine, Duke University, Durham, North Carolina, USA.
Sandeep
S
Vaishnavi
D000328:Adult; D000368:Aged; D003156:Community Mental Health Services / Q000191:economics / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy* / Q000191:economics / Q000235:genetics*; D008875:Middle Aged; D009483:Neuropsychological Tests; D010045:Outpatients; D000071185:Pharmacogenomic Testing / Q000191:economics / Q000379:methods*; D057285:Precision Medicine / Q000191:economics / Q000379:methods*; D011569:Psychiatric Status Rating Scales; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D011619:Psychotropic Drugs