A pharmacogenomic-based antidepressant treatment for patients with major depressive disorder: results from an 8-week, randomized, single-blinded clinical trial
Changsu Han 1, Sheng-Min Wang 2, 3, Won-Myoung Bahk 2, Soo-Jung Lee 2, Ashwin Patkar 4, Prakash Masand 5, Laura Mandelli 6, Chi-Un Pae 2, 4*, Alessandro Serrette 7
1Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea, 2Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea, 3International Health Care Center, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea, 4Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA, 5Global Medical Education, New York, NY, USA, 6Department of Biomedical and Neuromotor Sciences, Psychiatric Section, University of Bologna, Italy, 7Cell Death Disease Research Center, College of Medicine, The Catholic University of Korea, Seoul, Korea
Received: August 21, 2018; Accepted: August 27, 2018; Published online: August 27, 2018.
© The Korean College of Neuropsychopharmacology. All rights reserved.

Abstract
Background: Pharmacogenomic-based antidepressant treatment (PGATx) may result in more personalized pharmacotherapy of major depressive disorder (MDD) since PGATx may provide better drug therapy guidance.
Methods: An 8-week, randomized, single-blind clinical trial was conducted to evaluate the effectiveness and tolerability of PGATx in 100 patients with MDD. The genotyping was performed with the use of a commercial PGATx panel (Neuropharmagen®). All recruited patients were randomly allocated either to PGATx (N = 52) or treatment as usual (TAU, N= 48) groups. The primary endpoint was a change of total score of the Hamilton Depression Rating Scale-17 (HAMD-17) from baseline to end of treatment. Response rate (at least 50% reduction in HAMD-17 score from baseline), remission rate (HAMD-17 score ≤7 at the end of treatment) as well as the change of total score of Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) from baseline to end of treatment were also investigated.
Results: In the primary endpoints, the mean change of HAMD-17 score was significantly different between two groups favoring PGATx by –4.1 point of difference (P=0.010) at the end of treatment. The mean change in the FIBSER score from baseline was significantly different between two treatment groups favoring PGATx by –2.5 point of difference (P=0.028). In the secondary endpoints, the response rate (71.7 % vs. 43.6%, P=0.014) based on HAMD total score were also significantly higher in PGATx than in TAU at the end of treatment, while the remission rate was numerically higher in PGATx than in TAU groups without statistical difference (45.5% vs. 25.6%, P=0.071). The study completion rate was numerically higher in PGATx (75.0%) than in TAU (62.5%); the reason for early drop-out associated with adverse events was also numerically higher in TAU (N=9, 50.0%) than in PGATx (N=4, 30.8%).
Conclusion: The present study clearly demonstrate that PGATx may be a better treatment option in the treatment of MDD in terms of effectiveness and tolerability; however, study shortcomings may limit a generalization. Adequately-powered, well-designed, subsequent studies should be mandatory to prove its practicability and clinical utility for routine practice.
Keywords: major depressive disorder, pharmacogenomic testing, precision medicine, Antidepressant, clinical outcome, effectiveness, tolerability


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