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CTRI Number  CTRI/2024/04/066396 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of Adverse Drug Reactions and Potential Drug-Drug Interactions in Patients on Psychotropic Drugs 
Scientific Title of Study   A Descriptive study of Adverse Drug Reactions with Causality Assessment and Potential Drug Interactions in the Outpatients of the Psychiatric Department at SMS Hospital Jaipur.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kapil Goyal 
Designation  Junior Resident 
Affiliation  SMS Medical College 
Address  Department of Pharmacology, SMS Medical College, JLN Marg, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9772113166  
Fax    
Email  shanu.cool97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monica Jain 
Designation  Senior Professor 
Affiliation  SMS Medical College 
Address  Dr. Monica Jain, Department of Pharmacology, SMS Medical College, JLN Marg, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9828786533  
Fax    
Email  monicajain07@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Monica Jain 
Designation  Senior Professor 
Affiliation  SMS Medical College 
Address  Dr. Monica Jain, Department of Pharmacology, SMS Medical College, JLN Marg, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9828786533  
Fax    
Email  monicajain07@yahoo.com  
 
Source of Monetary or Material Support  
SMS Medical College, Jaipur, Rajasthan 
 
Primary Sponsor  
Name  Dr. Kapil Goyal 
Address  Department of Pharmacology, JLN Marg, Jaipur, Rajasthan (302004)  
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 Kapil Goyal  SMS Psychiatric Hospital  SMS Psychiatric Hospital, Opposite Pink Square Mall, Jaipur, Rajasthan (302004)
Jaipur
RAJASTHAN 		 9772113166

shanu.cool97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee SMS Medical College and Attached Hospital Jaipur  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  60.00 Year(s)
Gender  Both 
Details  1. Patients attending the Psychiatric OPD for follow up, who were diagnosed to be
suffering from any psychiatric illness and prescribed at least one psychotropic
drug.
2. Patients of either sex.
3. Patients in the age group of 18 years to 60 years.
4. Patients who will give informed consent. 
 
ExclusionCriteria 
Details  1. Patients having mental and behavioural disorders due to psychoactive substance use.
2. Patients who are pregnant/ lactating women.
3. Patients who are part of any other study.
4. Patients who will be non-co-operative. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To report and evaluate patterns of Adverse Drug Reactions (ADRs) occurring due
to psychotropic drugs.
2. To assess all the reported ADRs for Causality using WHO-UMC scale.
3. To study the potential drug-drug interactions (pDDIs) among different
psychotropic drugs as well as between psychotropic drugs and other co-prescribed
drugs by using Medscape software (online) (http://reference.medscape.com/druginteractionchecker). 		 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To process the reported ADRs to Indian Pharmacopoeia Commission (IPC)
Ghaziabad by using VIGIFLOW software.
2. To sensitize healthcare workers for reporting and submission of ADRs to ADR
Monitoring Center (AMC) at our institute.
3. To sensitize the patients and their attendants to report ADRs by distribution of
consumer ADR reporting forms. 		 6 Months 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   06/05/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Under-reporting is a problem with ADRs occurring due to psychotropic drugs. The need for this study is for observation and analysis of the ADRs occurring due to psychotropic drugs and then assessing all the reported ADRs for Causality using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale. Also, studying the potential drug-drug interactions (pDDIs) amongst different psychotropic drugs as well as between psychotropic drugs and other co-prescribed drugs by using Medscape software (online) (http://reference.medscape.com/drug-interactionchecker) will aid clinicians to achieve optimal therapeutic outcomes in patients by increasing awareness of clinically relevant psychotropic drug interactions. It will also help to sensitize the healthcare workers as well as the patients and their attendant for reporting of ADRs occurring due to psychotropic medications. 
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