A pharmacogenomic-based antidepressant treatment for patients with major depressive disorder: Results from an 8-week, randomized, single-blinded clinical trial

Changsu Han; Sheng Min Wang; Won Myong Bahk; Soo Jung Lee; Ashwin A. Patkar; Prakash S. Masand; Laura Mandelli; Chi Un Pae; Alessandro Serretti

doi:10.9758/cpn.2018.16.1.469

A pharmacogenomic-based antidepressant treatment for patients with major depressive disorder: Results from an 8-week, randomized, single-blinded clinical trial

Changsu Han, Sheng Min Wang, Won Myong Bahk, Soo Jung Lee, Ashwin A. Patkar, Prakash S. Masand, Laura Mandelli, Chi Un Pae, Alessandro Serretti

Research output: Contribution to journal › Article › peer-review

43 Citations (Scopus)

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.

Original language	English
Pages (from-to)	469-480
Number of pages	12
Journal	Clinical Psychopharmacology and Neuroscience
Volume	16
Issue number	4
DOIs	https://doi.org/10.9758/cpn.2018.16.1.469
Publication status	Published - 2018 Nov

Bibliographical note

Funding Information:
This study was supported by a grant from the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (grant number: HC15C1405), BL&H Co., Ltd. (Seoul, Korea), and AB-Biotics, S.A. (Barcelona, Spain; providing sample kits and pharmaco-genomics analysis). All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. Any funding sources did not involve in any kind of study design, results analyses, and writing support.

Publisher Copyright:
Copyright © 2018, Korean College of Neuropsychopharmacology.

Keywords

Antidepressants
Depressive disorder
Effects
Pharmacogenetic testing
Precision medicine
Tolerance.

ASJC Scopus subject areas

Psychiatry and Mental health
Behavioral Neuroscience
Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.9758/cpn.2018.16.1.469

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Han, C., Wang, S. M., Bahk, W. M., Lee, S. J., Patkar, A. A., Masand, P. S., Mandelli, L., Pae, C. U., & Serretti, A. (2018). A pharmacogenomic-based antidepressant treatment for patients with major depressive disorder: Results from an 8-week, randomized, single-blinded clinical trial. Clinical Psychopharmacology and Neuroscience, 16(4), 469-480. https://doi.org/10.9758/cpn.2018.16.1.469

A pharmacogenomic-based antidepressant treatment for patients with major depressive disorder: Results from an 8-week, randomized, single-blinded clinical trial. / Han, Changsu; Wang, Sheng Min; Bahk, Won Myong et al.
In: Clinical Psychopharmacology and Neuroscience, Vol. 16, No. 4, 11.2018, p. 469-480.

Research output: Contribution to journal › Article › peer-review

Han, C, Wang, SM, Bahk, WM, Lee, SJ, Patkar, AA, Masand, PS, Mandelli, L, Pae, CU & Serretti, A 2018, 'A pharmacogenomic-based antidepressant treatment for patients with major depressive disorder: Results from an 8-week, randomized, single-blinded clinical trial', Clinical Psychopharmacology and Neuroscience, vol. 16, no. 4, pp. 469-480. https://doi.org/10.9758/cpn.2018.16.1.469

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title = "A pharmacogenomic-based antidepressant treatment for patients with major depressive disorder: Results from an 8-week, randomized, single-blinded clinical trial",

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.",

keywords = "Antidepressants, Depressive disorder, Effects, Pharmacogenetic testing, Precision medicine, Tolerance.",

author = "Changsu Han and Wang, {Sheng Min} and Bahk, {Won Myong} and Lee, {Soo Jung} and Patkar, {Ashwin A.} and Masand, {Prakash S.} and Laura Mandelli and Pae, {Chi Un} and Alessandro Serretti",

note = "Funding Information: This study was supported by a grant from the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (grant number: HC15C1405), BL&H Co., Ltd. (Seoul, Korea), and AB-Biotics, S.A. (Barcelona, Spain; providing sample kits and pharmaco-genomics analysis). All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. Any funding sources did not involve in any kind of study design, results analyses, and writing support. Publisher Copyright: Copyright {\textcopyright} 2018, Korean College of Neuropsychopharmacology.",

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T1 - A pharmacogenomic-based antidepressant treatment for patients with major depressive disorder

T2 - Results from an 8-week, randomized, single-blinded clinical trial

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AU - Wang, Sheng Min

AU - Bahk, Won Myong

AU - Lee, Soo Jung

AU - Patkar, Ashwin A.

AU - Masand, Prakash S.

AU - Mandelli, Laura

AU - Pae, Chi Un

AU - Serretti, Alessandro

N1 - Funding Information: This study was supported by a grant from the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (grant number: HC15C1405), BL&H Co., Ltd. (Seoul, Korea), and AB-Biotics, S.A. (Barcelona, Spain; providing sample kits and pharmaco-genomics analysis). All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. Any funding sources did not involve in any kind of study design, results analyses, and writing support. Publisher Copyright: Copyright © 2018, Korean College of Neuropsychopharmacology.

PY - 2018/11

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N2 - 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.

AB - 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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KW - Precision medicine

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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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

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