tility of genetics-assisted treatment in patients with schizophrenia attending a tertiary care hospital in eastern India
Phase 4
- Conditions
- Health Condition 1: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2023/08/056210
- Lead Sponsor
- Indian Council of Medical Research (ICMR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult (>=18 years) patients of both gender attending the OPD of Psychiatry, AIIMS, Kalyani, diagnosed with schizophrenia (DSM V), and are adjudicated by the treating psychiatrist to be treated with one or more of the following first-line antipsychotic medicine: olanzapine, risperidone, haloperidol, amisulpride, quetiapine, aripiprazole, and trifluoperazine
Exclusion Criteria
Patients who are needed to be hospitalized or provided electroconvulsive therapy (ECT) at presentation, patients for whom any other antipsychotic drug is required to be initiated, and those who are unwilling to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in the Udvalg for Kliniske Undersøgelser Side-Effect Rating Scale (UKU-SERS) score between the two groupsTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method The proportion of patients developing solicited AEs & SAEs <br/ ><br> <br/ ><br>The proportion of patients requiring hospitalization <br/ ><br> <br/ ><br>Duration of hospitalization <br/ ><br> <br/ ><br>Clinical response at week 12 (PANSS & CGI) <br/ ><br> <br/ ><br>Time-to-achieve clinical response through 12 weeks (PANSS & CGI) <br/ ><br> <br/ ><br>The proportion of patients non-responsive to treatment <br/ ><br> <br/ ><br>Number & olanzapine-equivalent doses of various anti-psychotics <br/ ><br> <br/ ><br>Medication adherence <br/ ><br> <br/ ><br>Quality of life (EQ-5D-5L) <br/ ><br> <br/ ><br>Correlation between serum drug level, dosing, & clinical response <br/ ><br> <br/ ><br>Health outcomes in terms of life years, QALYs, & costs <br/ ><br> <br/ ><br>Facilitators & challenges in implementing PGx-assisted treatmentTimepoint: 12 weeks