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

by 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 ObjectivesThe 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. MethodsIn 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 genesDRD2,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 Unders øgelser 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 schi...
Source: PLoS One - Category: Biomedical Science Authors: Source Type: research