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 journalArticle

4 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 languageEnglish
Pages (from-to)469-480
Number of pages12
JournalClinical Psychopharmacology and Neuroscience
Volume16
Issue number4
DOIs
Publication statusPublished - 2018 Nov 1

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Pharmacogenetics
Major Depressive Disorder
Antidepressive Agents
Clinical Trials
Depression
Therapeutics
Drug Therapy

Keywords

  • Antidepressants
  • Depressive disorder
  • Effects
  • Pharmacogenetic testing
  • Precision medicine
  • Tolerance.

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Behavioral Neuroscience
  • Pharmacology (medical)

Cite this

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; Lee, Soo Jung; Patkar, Ashwin A.; Masand, Prakash S.; Mandelli, Laura; Pae, Chi Un; Serretti, Alessandro.

In: Clinical Psychopharmacology and Neuroscience, Vol. 16, No. 4, 01.11.2018, p. 469-480.

Research output: Contribution to journalArticle

Han, Changsu ; Wang, Sheng Min ; Bahk, Won Myong ; Lee, Soo Jung ; Patkar, Ashwin A. ; Masand, Prakash S. ; Mandelli, Laura ; Pae, Chi Un ; Serretti, Alessandro. / A pharmacogenomic-based antidepressant treatment for patients with major depressive disorder : Results from an 8-week, randomized, single-blinded clinical trial. In: Clinical Psychopharmacology and Neuroscience. 2018 ; Vol. 16, No. 4. pp. 469-480.
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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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AU - Lee, Soo Jung

AU - Patkar, Ashwin A.

AU - Masand, Prakash S.

AU - Mandelli, Laura

AU - Pae, Chi Un

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