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A Pharmacogenomic-based Antidepressant Treatment for Patients with Major Depressive Disorder: Results from an 8-week, Randomized, Single-blinded Clinical Trial

Won-Myong Bahk|Sheng Min Wang|Alessandro Serretti|Chi-Un Pae|Soo-Jung Lee|Ashwin A Patkar|Laura Mandelli|Changsu Han|Prakash S Masand
대한정신약물학회 (Korean College of Neuropsychopharmacology)|2018.11|Clinical Psychopharmacology and Neuroscience|제16권 제4호|pp. 469-480|DOI https://doi.org/10.9758/cpn.2018.16.1.469

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키워드

EffectsDepressive disorderAntidepressantsPrecision medicineTolerance.Pharmacogenetic testing

초록

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.

Abstract

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.

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관련 논문AI추천

A Practical Utility and Benefit of Pharmacogenetic-based Antidepressant Treatment Strategy for Major Depressive Disorder Patients with Difficult-to-treatAlessandro Serretti, Chi-Un Pae, Kyung Ho Lee, Soo-Jung Lee, Won-Myong Bahk대한정신약물학회 · Clinical Psychopharmacology and Neuroscience2021 · 제19권 제1호Improved Antidepressant Remission in Major Depression via a Pharmacokinetic Pathway Polygene Pharmacogenetic ReportAjeet B. Singh대한정신약물학회 · Clinical Psychopharmacology and Neuroscience2015 · 제13권 제2호Pharmacogenomic Study of Patients with Depression김도관, 임신원, Hyeran Kim대한정신약물학회 · Clinical Psychopharmacology and Neuroscience2008 · 제6권 제1호Pharmacogenetics and Depression: A Critical PerspectiveAlessandro Serretti, Chiara Fabbri, Filippo Corponi대한신경정신의학회 · PSYCHIATRY INVESTIGATION2019 · 제16권 제9호Genetics of Treatment Outcomes in Major Depressive Disorder: Present and FutureAlessandro Serretti, Chiara Fabbri대한정신약물학회 · Clinical Psychopharmacology and Neuroscience2020 · 제18권 제1호How to Utilize Clinical and Genetic Information for Personalized Treatment of Major Depressive Disorder: Step by Step Strategic ApproachAlessandro Serretti, Chiara Fabbri대한정신약물학회 · Clinical Psychopharmacology and Neuroscience2020 · 제18권 제4호

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