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Pharmacogenomics-assisted schizophrenia management: A hybrid type 2 effectiveness-implementation study protocol to compare the clinical utility, cost-effectiveness, and barriers

Author

Listed:
  • Aniruddha Basu
  • Atanu Kumar Dutta
  • Bhavani Shankara Bagepally
  • Saibal Das
  • Jerin Jose Cherian
  • Sudipto Roy
  • Pawan Kumar Maurya
  • Indranil Saha
  • Deepasree Sukumaran
  • Kumari Rina
  • Sucharita Mandal
  • Sukanto Sarkar
  • Manoj Kalita
  • Kalyan Bhowmik
  • Asim Saha
  • Amit Chakrabarti

Abstract

Objectives: The response to antipsychotic therapy is highly variable. Pharmacogenomic (PGx) factors play a major role in deciding the effectiveness and safety of antipsychotic drugs. A hybrid type 2 effectiveness-implementation research will be conducted to evaluate the clinical utility (safety and efficacy), cost-effectiveness, and facilitators and barriers in implementing PGx-assisted management compared to standard of care in patients with schizophrenia attending a tertiary care hospital in eastern India. Methods: In part 1, a randomized controlled trial will be conducted. Adult patients with schizophrenia will be randomized (2: 1) to receive PGx-assisted treatment (drug and regimen selection depending on the results of single-nucleotide polymorphisms in genes DRD2, HTR1A, HTR2C, ABCB1, CYP2D6, CYP3A5, and CYP1A2) or the standard of care. Serum drug levels will be measured. The patients will be followed up for 12 weeks. The primary endpoint is the difference in the Udvalg for Kliniske Undersøgelser Side-Effect Rating Scale score between the two arms. In part 2, the cost-effectiveness of PGx-assisted treatment will be evaluated. In part 3, the facilitators and barriers to implementing PGx-assisted treatment for schizophrenia will be explored using a qualitative design. Expected outcome: The study findings will help in understanding whether PGx-assisted management has a clinical utility, whether it is cost-effective, and what are the facilitators and barriers to implementing it in the management of schizophrenia. Trial registration: The study has been registered with the Clinical Trials Registry–India (CTRI/2023/08/056210).

Suggested Citation

  • Aniruddha Basu & Atanu Kumar Dutta & Bhavani Shankara Bagepally & Saibal Das & Jerin Jose Cherian & Sudipto Roy & Pawan Kumar Maurya & Indranil Saha & Deepasree Sukumaran & Kumari Rina & Sucharita Man, 2024. "Pharmacogenomics-assisted schizophrenia management: A hybrid type 2 effectiveness-implementation study protocol to compare the clinical utility, cost-effectiveness, and barriers," PLOS ONE, Public Library of Science, vol. 19(4), pages 1-15, April.
    • Handle: RePEc:plo:pone00:0300511
    DOI: 10.1371/journal.pone.0300511
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    1. repec:plo:pone00:0218711 is not listed on IDEAS
    2. Greg Guest & Emily Namey & Mario Chen, 2020. "A simple method to assess and report thematic saturation in qualitative research," PLOS ONE, Public Library of Science, vol. 15(5), pages 1-17, May.
    3. Shankar Prinja & Yashika Chugh & Kavitha Rajsekar & V. R. Muraleedharan, 2021. "National Methodological Guidelines to Conduct Budget Impact Analysis for Health Technology Assessment in India," Applied Health Economics and Health Policy, Springer, vol. 19(6), pages 811-823, November.
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