Individualized insights to guide and monitor pharmacotherapy
Major depressive disorder (MDD) and associated mood syndromes are among the most common mental health disorders and a continually expanding burden on health care systems. For patients affected by these complex syndromes — which vary in clinical presentation — timely, effective treatment can have a positive impact on their quality of life.
Use of precision therapeutics, which combines pharmacogenomic (PGx) testing with therapeutic drug monitoring (TDM), to manage mood disorders provides physicians and psychiatrists with personalized insights to identify and avoid adverse drug reactions. In instances of poor treatment response, PGx facilitates developing individualized treatment plans based on probable medication response.
21 million
21 million adults in the U.S. are affected by mood disorders1
$326 billion
$326 billion economic burden in the U.S. to treat MDD in 20182
30-40%
30 - 40% of patients affected by MDD do not respond to therapy3
PGx testing can help guide medication selection in individuals with treatment-related depression and those with metabolic variations that impact treatment efficacy. Results from our comprehensive panel can increase understanding of an individual’s genetic makeup to help personalize dosing decisions.
Multi-gene panel that identifies genetic variation in genes known to be associated with response and/or risk of toxicity with psychotropic medications.
Examines 23 genes (141 alleles) used to assess approximately 80 medications.
Single gene genotyping
Inter-individual differences in tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs) pharmacokinetic parameters and treatment outcomes are associated with CYP2D6 and CYP2C19 genetic variants. With some drugs being affected by CYP2D6 only (e.g., amitriptyline) and others by both polymorphic enzymes (e.g., clomipramine), focused testing is recommended.
Singe-gene assessment useful for identifying patients who may be at risk for altered metabolism of drugs metabolized by cytochrome P450 2C19.
Hypersensitivity monitoring
Human leukocyte antigen (HLA) genetic variation is implicated in the development of specific cutaneous adverse reactions to aromatic anticonvulsants. To reduce the incidence of serious, and sometimes fatal, cutaneous adverse reactions to carbamazepine and oxcarbazepine, identifying those who are at significant risk through HLA-B*15:02 and HLA-A*31:01 genotyping is recommended.
Known drug-gene associations
The variant allele HLA-B*15:02 is strongly associated with greater risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in patients treated with carbamazepine or oxcarbazepine.
The variant allele HLA-A*31:01 is associated with greater risk of maculopapular exanthema, drug reaction with eosinophilia and systemic symptoms, and SJS/TEN in patients treated with carbamazepine.
Useful for monitoring amitriptyline and nortriptyline serum concentrations during therapy to avoid toxicity, especially in children and poor metabolizers of CYP2D6.
Useful for monitoring patients exhibiting symptoms of carbamazepine toxicity whose total serum carbamazepine concentration is within the therapeutic range, but who may be producing significant levels of the active metabolite epoxide, which can accumulate to concentrations equivalent to carbamazepine.
Ann Moyer, M.D., Ph.D., and Paul Jannetto, Ph.D., explain how precision therapeutics can improve treatment for patients with major depressive disorder. The optimal antidepressant medication and dose vary among individuals. Pharmacogenomic testing and therapeutic drug monitoring can guide clinicians to the most-effective treatment for each patient.
Greenberg P, Fournier A-A, Sisitsky T, et al. The economic burden of adults with major depressive disorder in the United States (2010 and 2018). Pharmacoeconomics. 2021. 10.1007/s40273-021-01019-4
Undurraga J, Baldessarini RJ. Randomized, placebo-controlled trials of antidepressants for acute major depression: thirty-year meta-analytic review. Neuropsychopharmacology. 2012;37:851–64.
Hicks JK, Sangkuhl K, Swen JJ, et al. Clinical pharmacogenetics implementation consortium guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants: 2016 update. Clin Pharmacol Ther. 2017 Jul; 102:1, 37-44. TCA 2016 (cpicpgx.org)
Hicks JK, Bishop JR, Sangkuhl K, et al. Clinical pharmacogenetics implementation consortium (CPIC) guideline for CYP2D6 and CYP2C19 genotypes and dosing of selective serotonin reuptake inhibitors. Clin Pharmacol Ther. 2015 Aug; 98:2, 127-134. 25974703 (cpicpgx.org)
Phillips E, Sukasem C, Whirl-Carrillo M, et al. Clinical pharmacogenetics implementation consortium guideline for HLA genotype and use of carbamazepine and oxcarbazepine: 2017 update. Clin Pharmacol Ther. 2018 March. CPIC HLA CBZ OXC (cpicpgx.org)
Hiemke C, Bergemann N, Clement HW, et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology. Pharmacopsychiatry. 2018;51. 9-62. http://dx.doi.org/10.1055/s-0043-116492
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