Clin Psychopharmacol Neurosci 2018; 16(4): 469-480  
A Pharmacogenomic-based Antidepressant Treatment for Patients with Major Depressive Disorder: Results from an 8-week, Randomized, Single-blinded Clinical Trial
Changsu Han1, Sheng-Min Wang2,3, Won-Myong Bahk2, Soo-Jung Lee2, Ashwin A. Patkar4, Prakash S. Masand5, Laura Mandelli6, Chi-Un Pae2,4,7, Alessandro Serretti6
1Department of Psychiatry, Korea University College of Medicine, Seoul, 2Department of Psychiatry and 7Cell Death Disease Research Center, College of Medicine, The Catholic University of Korea, Seoul, 3International Health Care Center, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea, 4Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, 5Global Medical Education, New York, NY, USA, 6Department of Biomedical and Neuromotor Sciences, Psychiatric Section, University of Bologna, Bologna, Italy
Correspondence to: Chi-Un Pae, MD, PhD
Department of Psychiatry, The Catholic University of Korea, Bucheon St. Mary’s Hospital, 327 Sosa-ro, Wonmi-gu, Bucheon 14647, Korea
Tel: +82-32-340-7067, Fax: +82-32-340-2255
Received: August 21, 2018; Accepted: August 27, 2018; Published online: November 30, 2018.
© The Korean College of Neuropsychopharmacology. All rights reserved.

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Objective: Pharmacogenomic-based antidepressant treatment (PGATx) may result in more precise pharmacotherapy of major depressive disorder (MDD) with 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. 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: 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). The response rate (71.7 % vs. 43.6%, p=0.014) 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 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: Depressive disorder; Pharmacogenetic testing; Antidepressants; Precision medicine; Effects; Tolerance.

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  • Ministry of Health and Welfare(Ministry of Health, Welfare and Family Affairs)

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