PRIME Care
Trial question
What is the effect of pharmacogenomic testing for drug-gene interactions in patients with major depressive disorder?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 1944
1944 patients (491 female, 1453 male).
Inclusion criteria: adult patients with major depressive disorder who were initiating or switching treatment with a single antidepressant.
Key exclusion criteria: active substance use disorder; mania; psychosis; concurrent treatment with a specified list of medications.
Interventions
N=966 pharmacogenomic-guided testing (results from a commercial pharmacogenomic test were given to clinicians).
N=978 usual care (usual care and access to pharmacogenomic results after 24 weeks).
Primary outcome
Estimated chance of no drug-gene interaction
59.3%
25.7%
59.3 %
44.5 %
29.6 %
14.8 %
0.0 %
Pharmacogenomic-guided
testing
Usual
care
Significant
increase ▲
NNH = 2
Significant increase in estimated chance of no drug-gene interaction (59.3% vs. 25.7%; AD 33.6%, 95% CI 28.9 to 38.4).
Secondary outcomes
Significant increase in the rate of symptom remission over 24 weeks (17.2% vs. 16%; OR 1.28, 95% CI 1.05 to 1.57).
Significant decrease in estimated risk of moderate drug-gene interaction (30% vs. 54.6%; ARD -24.6, 95% CI -29.5 to -19.7).
Significant decrease in estimated risk of substantial drug-gene interaction (10.7% vs. 19.7%; ARD -9, 95% CI -12.7 to -5.3).
Conclusion
In adult patients with major depressive disorder who were initiating or switching treatment with a single antidepressant, pharmacogenomic-guided testing was superior to usual care with respect to estimated chance of no drug-gene interaction.
Reference
David W Oslin, Kevin G Lynch, Mei-Chiung Shih et al. 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.
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