Journal Article

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

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

2024

Overview

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. 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. 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. The study has been registered with the Clinical Trials Registry-India (CTRI/2023/08/056210).

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Adult / Antipsychotic Agents - adverse effects / Antipsychotic Agents - therapeutic use / Biology and Life Sciences / Cost-Benefit Analysis / Humans / India / Medicine and Health Sciences / People and Places / Pharmacogenetics / Randomized Controlled Trials as Topic / Schizophrenia - drug therapy / Schizophrenia - genetics / Social Sciences / Study Protocol