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2. Does Pharmacogenomic Testing Improve Outcomes? The Evidence
Simon Kung, M.D.
Associate Professor of Psychiatry
Mayo Clinic

3. How Useful is Pharmacogenomic Testing?
GeneSigh t
Genomind
2 studies
1 study
1 study
Rosenblat, J. D., Lee, Y., & McIntyre, R. S. (2017). Does pharmacogenomic testing improve clinical outcomes for major depressive disorder? a systematic review of clinical trials and cost-effectiveness studies. The Journal of clinical psychiatry, 78(6),

4. Open-label, prospective, 8-week study
GeneSight Study 1
Reduction in depressive symptoms
Genotyping group n=22
31%
QIDS-C16
Open-label, prospective, 8-week study
Reduction in depressive symptoms
Control n=22
7.2%
QIDS-C16
Hall-Flavin, D. K., Winner, J. G., Allen, J. D., Jordan, J. J., Nesheim, R. S., Snyder, K. A., ... & Mrazek, D. A. (2012). Using a pharmacogenomic algorithm to guide the treatment of depression. Translational psychiatry, 2(10), e172.

5. Open-label, prospective, 8-week study
GeneSight Study 2
Reduction in depressive symptoms
Genotyping group n=114
44.8%
Open-label, prospective, 8-week study
Reduction in depressive symptoms
Control n=113
26.4%
Hall-Flavin, D. K., Winner, J. G., Allen, J. D., Carhart, J. M., Proctor, B., Snyder, K. A., ... & Mrazek, D. A. (2013). Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenetics and genomics, 23(10),

6. GeneSight Study 3: The First Double-Blinded Study
Genotyping n=26
Symptom improvement
31%
HAMD-17
Double-blind, 10- week study
Control n=25
Symptom improvement
21%
HAMD-17
Winner, J. G., Carhart, J. M., Altar, A., Allen, J. D., & Dechairo, B. M. (2013). A prospective, randomized, double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder. Discovery medicine, 16(89),

7. Genecept Naturalistic Study
39% response rate, improved QOL, fewer side effects
3-month study, n=685
No comparison group, diagnoses were heterogeneous
Surveys
Brennan, F. X., Gardner, K. R., Lombard, J., Perlis, R. H., Fava, M., Harris, H. W., & Scott, R. (2015). A naturalistic study of the effectiveness of pharmacogenetic testing to guide treatment in psychiatric patients with mood and anxiety disorders. The primary care companion for CNS disorders, 17(2).

8. Dr. Singh and the CNSDose Panel Study
Genotype guided 
n=74
Remission rate
72%
RCT
Unguided n=74
Remission rate
28%
Singh, A. B. (2015). Improved antidepressant remission in major depression via a pharmacokinetic pathway polygene pharmacogenetic report. Clinical Psychopharmacology and Neuroscience, 13(2), 150. 

9. The Pérez Prospective, Muticenter Trial
Genotyping n=155
Sustained response
Higher response rate
Fewer side effects
38.5%
Multicenter RCT
Control n=161
Sustained response
34.4%
Pérez, V., Salavert, A., Espadaler, J., Tuson, M., Saiz-Ruiz, J., Sáez-Navarro, C., ... & Rodriguez-Jimenez, R. (2017). Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial. BMC psychiatry, 17(1), 250.

10. Dr. Greden’s Prospective, Double-Blinded Study
Better response and remission rates
Genotyping group
Randomized, double- blind trial n=1167
Treatment as usual
Greden JF. (2018). Combinatorial Pharmacogenomics Significantly Improves Response and Remission for Major Depressive Disorder: A Double-Blind, Randomized Control Trial. American Psychiatric Association Annual Meeting.

11. Pharmacogenetic Panel Testing: Not Ready for Prime Time?
Insufficient data to support the widespread use of this testing in clinical practice
4 different pharmacogenomic panel tests
The technology may be informative in predicting side effects
Zeier, Z., Carpenter, L. L., Kalin, N. H., Rodriguez, C. I., McDonald, W. M., Widge, A. S., & Nemeroff, C. B. (2018). Clinical Implementation of Pharmacogenetic Decision Support Tools for Antidepressant Drug Prescribing. American Journal of Psychiatry, appi-ajp.

12. Declared conflicts of interest
Adequate sample size
Proper randomization
Future
Pharmacogenomic
Studies
Appropriate population
Appropriate matching
Declared conflicts of interest
Proper blinding
Better comparators
Zubenko, G. S., Sommer, B. R., & Cohen, B. M. (2018). On the Marketing and Use of Pharmacogenetic Tests for Psychiatric Treatment. JAMA psychiatry.

13. Key Points
There is now evidence that pharmacogenomic panels can improve psychiatry patient outcomes.
The studies are all industry-funded or industry-supported, and there are methodologic limitations, such as small sample size or inadequate blinding.
More research is needed to reach stronger conclusions.

14. Next Presentation Pharmacogenomics in Clinical Practice: Recommendations and Communicating with Patients