Preliminary Clinical Investigation of Combinatorial Pharmacogenomic Testing for the Optimized Treatment of Depression: A Randomized Single-Blind Study

Abstract

This study aims to explore the potential benefits of antidepressant drugs related to metabolic enzyme and drug-targeted genes, identify the optimal treatment of major depression, and provide a reference for individualized medication selection. A prospective randomized single-blind investigation was conducted for 8 weeks. A pharmacogenomic-based interpretive report was provided to the treating physician in the guided group. Patients in this group were informed that their medication selection was directed by DNA testing. In the unguided group, treatment was provided based on the clinical experience of the physician without the guidance of pharmacogenomic testing. Pharmacogenomic-based interpretive report was not provided to these patients until treatment completion. The 17-item Hamilton depression scale (HAMD-17), Hamilton anxiety scale, and treatment emergent symptom scale were used to assess the clinical efficacy and side effects at baseline and after 2, 4, and 8 weeks of treatment. Among the 80 initially enrolled patients with depression, 71 participated in the full data analysis sets and were designated into guided (31) and unguided (40) groups, respectively. No significant difference (P > 0.05) in HAMD-17 total scores, response and remission rates was found between the guided and unguided groups at the end of the treatment. The incidence rate of adverse reaction was 55.56% in guided group and 57.89% in the unguided group. Our study suggested that pharmacogenomic testing might not considerably improve the clinical efficiency and safety for the guided group.

An Effective Method to Facilitate Personalized and Precise Medicine for Schizophrenia Treatment Based on Pharmacogenomics

“…Precision medicine is the trend for future medical practices. While there were already quite a few successful reports about the pharmacogenomic-based genetic test guiding the treatment for psychiatric diseases in North American and European clinical services [8][9][10][11][12][13][14][15][16], there were still voices in China arguing against it [42]. One major practical conclusion we can get from this study, is that patients whose genetic pro les match their medication treatment tend to have better e cacy in the long term.…”

Pharmacogenomic Testing and Depressive Symptom Remission: A Systematic Review and Meta‐Analysis of Prospective, Controlled Clinical Trials

“…Last, with the exception of the Shan et al . 30 and Oslin et al . 33 trials, all studies were industry sponsored, a study attribute that has been linked to more favorable outcomes in drug and device studies.…”

“…After removal of duplicates, the abstracts of 150 articles were screened and 132 were excluded for not meeting our eligibility criteria, resulting in 24 articles for retrieval and full text review. Among these 24 articles, 16 did not meet eligibility criteria, leaving a total of 8 new trials in addition to the five previously analyzed RCTs 22‐33 …”

“…Among these 24 articles, 16 did not meet eligibility criteria, leaving a total of 8 new trials in addition to the five previously analyzed RCTs. 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 …”

“…trial. 30 Ten of the 13 trials were preregistered at clinicaltrials.gov or similar registry and appeared to adhere to the initial protocol. 23 , 24 , 25 , 26 , 27 , 29 , 31 , 32 , 33 , 34 , 35 , 36 …”