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Utility of genetics-assisted treatment in patients with schizophrenia attending a tertiary care hospital in eastern India

Clinical utility and cost-effectiveness of pharmacogenomics-assisted treatment versus standard of care in patients with schizophrenia attending a tertiary care hospital in eastern India - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056210
Enrollment
250
Registered
2023-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F209- Schizophrenia, unspecified

Interventions

Intervention1: PGx-assisted antipsychotic medication selection and dosing: PGx-assisted antipsychotic medication selection and dosing: patients will receive PGx-assisted therapy (drug and dose selecti

Sponsors

Indian Council of Medical Research (ICMR)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The difference in the Udvalg for Kliniske Undersøgelser Side-Effect Rating Scale (UKU-SERS) score between the two groupsTimepoint: 12 weeks

Secondary

MeasureTime frame
The proportion of patients developing solicited AEs & SAEs The proportion of patients requiring hospitalization Duration of hospitalization Clinical response at week 12 (PANSS & CGI) Time-to-achieve clinical response through 12 weeks (PANSS & CGI) The proportion of patients non-responsive to treatment Number & olanzapine-equivalent doses of various anti-psychotics Medication adherence Quality of life (EQ-5D-5L) Correlation between serum drug level, dosing, & clinical response Health outcomes in terms of life years, QALYs, & costs Facilitators & challenges in implementing PGx-assisted treatmentTimepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Aniruddha Basu

Indian Council of Medical Research - Centre for Ageing and Mental Health

saibal.das@icmr.gov.in8072486512

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026