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CTRI Number  CTRI/2018/03/012533 [Registered on: 13/03/2018] Trial Registered Prospectively
Last Modified On: 16/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on prescription patterns, adverse drug reactions and medication awareness in Schizophrenia patients 
Scientific Title of Study   Evaluation of prescription patterns, adverse drug reactions and awareness of drug treatment in patients of Schizophrenia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raakhi Tripathi 
Designation  Dr 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Pharmacology and Therapeutics, 1st floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9821724700  
Fax    
Email  lookon@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nishtha Khatri 
Designation  Dr 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Pharmacology and Therapeutics, 1st floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai
5, Madhuban building, Guru Gangeshwar Road, Khar west, 10 th road, Mumbai-400052
Mumbai
MAHARASHTRA
400012
India 
Phone  9769155547  
Fax    
Email  nkhatri115@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nishtha Khatri 
Designation  Dr 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Pharmacology and Therapeutics, 1st floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai
5, Madhuban building, Guru Gangeshwar Road, Khar west, 10 th road, Mumbai-400052
Mumbai
MAHARASHTRA
400012
India 
Phone  9769155547  
Fax    
Email  nkhatri115@gmail.com  
 
Source of Monetary or Material Support  
Diamond Jubilee Society Trust, KEM Hospital 
 
Primary Sponsor  
Name  Seth GS Medcial College and KEM Hospital 
Address  Acharya Donde Marg, Parel, Mumbai-400012, Maharashtra. 
Type of Sponsor  Government medical college 
 
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 Raakhi Tripathi  Seth GS Medical College and KEM Hospital  Psychiatry OPD no. 112, KEM Hospital, Acharya Donde, Parel, Mumbai-400012.
Mumbai
MAHARASHTRA 
9821724700

lookon@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Seth GS Medical College and KEM Hospital)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Schizophrenia patients diagnosed as per DSM-V criteria and their caregivers, (1) ICD-10 Condition: F209||Schizophrenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Inclusion Criteria for patients:

1. Male or female patients with age 18-65 years, attending Psychiatry OPD for existing Schizophrenia diagnosed as per DSM-V Criteria
2. Patients carrying treatment records prescribed at Psychiatry OPD of KEM Hospital, containing antipsychotic medication regimen for at least 3 months
3. For patients who will be given the drug awareness questionnaire, insight score equal to or above 9 on Birchwood insight scale thereby suggesting that patient has good insight

Inclusion criteria for the caregivers:
1.Primary caregivers of the patient.
2. Those who give written informed consent 
 
ExclusionCriteria 
Details  Exclusion Criteria for patients:

1.Patients admitted to psychiatry IPD and emergency department as well as referred patients
2. Newly diagnosed and treatment-naive patients
3.Patients with a history of Substance dependence or abuse at the current visit.
4.Patients with other Neurological disorders (dementia, delirium, and other cognitive disorders), seizure disorders, with sensory impairment and other psychiatric disorders such as mood disorders, and anxiety disorders.
5.Critically ill patients requiring urgent attention to medical problems

Exclusion criteria for the caregivers:
1. Those with age < 18 years and > 65 years
2. Those having neurological disorders such as dementia, delirium and other cognitive disorders
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To study the awareness of drug treatment in Schizophrenic patients having insight  Single point (cross sectional study), 18 months duration 
 
Secondary Outcome  
Outcome  TimePoints 
To study the awareness of drug treatment in Schizophrenic patients having insight  Single point (cross sectional study), 18 months duration 
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/03/2018 
Date of Study Completion (India) 30/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Schizophrenia is a chronic and complex mental illness consisting of a heterogeneous group of symptoms. It is associated with high relapse rates and medication adherence is found to be one of the contributing factor towards relapse. Since medication adherence and treatment awareness are found to be linked to each other, an alarming need was felt to evaluate the level of drug treatment awareness in patients suffering from schizophrenia. Based on the chronicity and debilitating nature of the disease, patients suffering from schizophrenia are often dependent on their caregivers. Hence, the role of caregivers cannot be disregarded and the need to assess treatment awareness among caregivers was also found to be important.

 

Prescription pattern studies conducted in schizophrenia have shown a variability in utilization of antipsychotics based on the geographical location of the study setting. Some settings prefer the use of typical antipsychotics while some preferred atypical antipsychotics. We felt that there was a need to study the prescription patterns in our setting. To add to this, we found that there were only a sparse number of studies which were specifically related to adverse drug reactions in schizophrenia. Adverse drug reactions due to antipsychotics can be deleterious for the patients thereby warranting a continuous surveillance so that precautionary measures can be taken to prevent their occurrence. Moreover, adverse drug reaction assessment would be of help to gauge the incidence as well as types of reactions specific to the study setting. 

 

Taking this into consideration, the current study was conceptualised to conduct a thorough evaluation of all these three factors in the very same study setting i.e., drug treatment awareness, prescription patterns and adverse drug reactions in schizophrenia patients. The study was also planned to evaluate the drug treatment awareness in caregivers of the patients undergoing treatment for schizophrenia. Patients who were diagnosed to have schizophrenia as per the DSM-V criteria and who were on antipsychotic medications for at least 3 months’ duration, were included. A total of 250 and 157 caregivers were recruited in the study over a duration of 18 months.

 

Majority of the patients (66 %) and caregivers (65 %) enrolled in this study were males.  166 patients had good insight and were administered the patient drug awareness questionnaire. Maximum percentage of correct responses (~93 %) on the patient drug awareness questionnaire were obtained in the domains related to the importance of preserving past prescriptions and importance of doctor-patient interaction. Minimum percentage of correct responses were seen in the side effects domain (52.41 %) and in the current prescription domain (66.42 %) and in synchrony with the % of correct responses, minimum awareness was seen in these two domains. The overall drug treatment awareness score in patients was found to be 12.57 Â±1.81 out of a maximum possible score of 17. Patient age, gender, socio-economic status and duration of disease did not show a statistically significant correlation with drug awareness scores. A weak positive correlation was found between the patient education status and drug awareness scores. However, this weak correlation cannot be considered as clinically significant. Similar results were seen with caregivers where again the maximum awareness and maximum percentage of correct responses were obtained in the domains related to the importance of preserving past prescriptions (98.73 %) and importance of doctor-patient interaction (93 %). The percentage of caregivers aware and answering correctly were minimum in side effects domain (~58 %) and in current prescription domain (~65 %). The overall drug treatment awareness score in caregivers was found to be 12.84 Â± 1.91 out of a maximum of 17. Age and gender of caregivers did not show a statistically significant correlation with drug awareness scores. A weak positive correlation was found between caregiver drug awareness scores and their socio-economic status as well as education status. However, this weak correlation cannot be considered as clinically significant. No statistically significant difference (at p<0.05) was found between the domain wise and overall awareness scores of patients and caregivers. 

 

Prescription pattern analysis showed that the average number of drugs per encounter were 3.11 while the average number of antipsychotics per encounter were 1.44. % prescriptions that were found to be complete were 88.54 %. Almost 89 % of the prescriptions were found to be complete. Risperidone and olanzapine were the most commonly prescribed antipsychotic drugs while trihexyphenidyl was the most frequently prescribed concomitant medication. A total of 67 cases of adverse events were recorded and on conducting a causality assessment, 37 were found to be causally related. Among the 37 cases of adverse drug reactions that were recorded, amenorrhea, sedation and weight gain were found to be the most common. Majority of ADRs (23 cases) were attributable to risperidone. Maximum proportion of the ADRs were possibly related to the medication and were of mild severity in addition to being non-preventable.

 

 

 
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