CTRI Number |
CTRI/2021/04/033286 [Registered on: 30/04/2021] Trial Registered Prospectively |
Last Modified On: |
29/04/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Other |
Public Title of Study
|
Polypharmacy of antipsychotics in Schizophrenia |
Scientific Title of Study
|
Pharmacotherapy, polypharmacy and adverse drug reactions of antipsychotics in patients with Schizophrenia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Paul Mathew |
Designation |
Post graduate Pharmacology |
Affiliation |
st johns medical college bangalore |
Address |
Dept of pharmacology
st johns medical college
Kormangala Bangalore st johns medical college kormangala bangalore 560034 Bangalore KARNATAKA 560034 India |
Phone |
8792142968 |
Fax |
|
Email |
paulmathewster@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Mangala Rao |
Designation |
Assistant Professor |
Affiliation |
Ragiv Gandhi university of health sciences |
Address |
Dept of Pharmacology
st Johns medical college
Kormangala Bangalore st johns medical college kormangala bangalore 560034 Bangalore KARNATAKA 560034 India |
Phone |
7337729453 |
Fax |
|
Email |
mangalarao75@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Paul Mathew |
Designation |
Post graduate Pharmacology |
Affiliation |
Ragiv Gandhi university of health sciences |
Address |
Dept of Pharmacology
st johns medical college kormangala bangalore 560034 st johns medical college kormangala bangalore 560034 Bangalore KARNATAKA 560034 India |
Phone |
8792142968 |
Fax |
|
Email |
paulmathewster@gmail.com |
|
Source of Monetary or Material Support
|
st johns medical college Bangalore |
|
Primary Sponsor
|
Name |
Paul Mathew |
Address |
st johns medical college Bangalore 560034 |
Type of Sponsor |
Other [self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Paul Mathew |
St Johns medical college |
Psychiatry OPD
st johns medical college
Kormangala,Bangalore 560034 Bangalore KARNATAKA |
8792142968
paulmathewster@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee St Johns Medical College Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
1. Consenting adult patients (age ≥ 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
|
|
ExclusionCriteria |
Details |
1.Patients who are unable to give information on their own
2.Patients unable to come for 3 months follow up
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
oTo evaluate the pharmacotherapy and prevalence of polypharmacy in the treatment of schizophrenia
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
|
Outcome |
TimePoints |
•To assess the quality of life in patients with schizophrenia |
3 months |
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
10/05/2021 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="8" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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. |