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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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