Polypharmacy of antipsychotics in Schizophrenia

Not yet recruiting

Conditions: Mental, Behavioral and Neurodevelopmental disorders,

Registration Number: CTRI/2021/04/033286

Lead Sponsor: Paul Mathew

Brief Summary: Schizophrenia is among the most disabling catastrophic medical disorders. The main stay of treatment in schizophrenia is pharmacotherapy. In the last decade there have been newer antipsychotics (second and third generation antipsychotics). Patients with schizophrenia are treated either with monotherapy or polytherapy depending on various factors like symptoms, duration of disease, response to treatment etc. The use of antipsychotic polypharmacy has raised concerns owing to the lack of evidence for its efficacy and safety as well as variable justifications and practice patterns.

Adverse drug reactions (ADR) to pharmacotherapy is a factor contributing to adherence to medications. The ADRs mainly reported are, extra pyramidal side effects, tachycardia, tremors, rigidity. The extra pyramidal side effects are reported more with the first generation antipsychotics.8 The adverse drug reactions in second and third generation are mainly metabolic syndrome.8

Quality of life (QOL) is an important measure of psychiatric disorders. Studies have reported low QOL in patients with schizophrenia.7,13 Assessment of QOL in patients with schizophrenia coming to a tertiary care hospital and the impact of treatment on QOL is useful.

Precise knowledge of how drugs are being prescribed and utilized, helps to suggest measures to improve prescribing habits. Hence the study of pharmacotherapy and the prevalence of antipsychotic polypharmacy in our set up is relevant. On literature review we found studies reporting ADRs with regards to antipsychotic use in general or individual drugs. Few studies have reported the proportion of ADRs among patients with Schizophrenia in monotherapy and antipsychotic polypharmacy groups. Hence, we also plan to estimate the proportion of ADRs in these two groups in this study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 104

Inclusion Criteria

Consenting adult patients (age â‰¥ 18 years, both genders) with psychiatrist confirmed diagnosis of schizophrenia with ICD 10 criteria 2.
On antipsychotic drugs for more than or equal to 6 months.

Exclusion Criteria

1.Patients who are unable to give information on their own 2.Patients unable to come for 3 months follow up.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oTo evaluate the pharmacotherapy and prevalence of polypharmacy in the treatment of schizophrenia	Baseline and 3 months follow up
oTo estimate the proportion of adverse drug reactions in patients receiving monotherapy and antipsychotic polypharmacy for schizophrenia	Baseline and 3 months follow up

Secondary Outcome Measures

Name	Time	Method
â€¢To assess the quality of life in patients with schizophrenia	3 months

Trial Locations

Locations (1): St Johns medical college
🇮🇳
Bangalore, KARNATAKA, India
St Johns medical college
🇮🇳Bangalore, KARNATAKA, India
Dr Paul Mathew
Principal investigator
8792142968
paulmathewster@gmail.com