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CTRI Number  CTRI/2024/11/076611 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   "Understanding How Benzodiazepine Prescriptions and Long-Term Use Affect Dependency in Psychiatry Patients" 
Scientific Title of Study   Study of Benzodiazepine Prescription Pattern and Dependence among Psychiatric Outpatients on Prescribed Benzodiazepine over Long Term 
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 Shafiq Ahmed 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College and Hospital 
Address  Department of psychiatry Jawaharlal Nehru Medical College, AMU campus ,Medical road Aligarh,Uttar Pradesh ,202002,India

Aligarh
UTTAR PRADESH
202002
India 
Phone  9797499747  
Fax    
Email  sfq0911@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Reyazuddin 
Designation  Associate Professor 
Affiliation  JawaharLal Nehru Medical College 
Address  Department of psychiatry Jawaharlal Nehru Medical College, AMU campus ,Medical road Aligarh,Uttar Pradesh
Department of psychiatry Jawaharlal Nehru Medical College, AMU campus ,Medical road Aligarh,Uttar Pradesh
Aligarh
UTTAR PRADESH
202002
India 
Phone  09797499747  
Fax    
Email  reyaz39@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohammad Reyazuddin 
Designation  Associate Professor 
Affiliation  JawaharLal Nehru Medical College 
Address  Department of psychiatry Jawaharlal Nehru Medical College, AMU campus ,Medical road Aligarh,Uttar Pradesh
Department of psychiatry Jawaharlal Nehru Medical College, AMU campus ,Medical road Aligarh,Uttar Pradesh
Aligarh
UTTAR PRADESH
202002
India 
Phone  09797499747  
Fax    
Email  reyaz39@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College,Aligarh Muslim University ,Medical College road,AMU campus,Aligarh,UP,202002,INDIA 
 
Primary Sponsor  
Name  Dr Shafiq Ahmed 
Address  Department of Psychiatry Jawaharlal Nehru Medical College,AMU campus,Medical Road,Aligarh,Uttar Pradesh,202002,India 
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 Shafiq Ahmed  Jawaharlal Nehru Medical College and Hospital  Department of psychiatry Jawaharlal Nehru Medical College, AMU campus ,Medical road Aligarh,Uttar Pradesh
Aligarh
UTTAR PRADESH 		 09797499747

sfq0911@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Regd.),Jawaharlal Nehru Medical College and Hospital, Faculty of Medicine, Aligarh Muslim University Aligarh, India - 202002  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G||Mental Health,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients taking prescribed benzodiazepine for atleast 3 months.
2.Patients 18 years or above.
3.both the genders.
4.patients/caregivers giving informed written consent to participate in study. 
 
ExclusionCriteria 
Details  1.patients below 18 years .
2.patients with intellectual disabilities.
3.patients with a diagnosis of dementia or cognitive impairment.
4.patients having features of psychosis.
5.patients/caregivers who will not give consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To study the patterns of benzodiazepine prescription (including dosage,frequency,and duration of use)among psychiatric outpatients.
2.To determine the prevalance of benzodiazepine dependance among psychiatry outpatients who are on prescribed benzodiazepine over lonf term. 		 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.to determine clinico-demographic correlates and risk factors for developing benzodiazepine dependence.
2.to asses the awareness,knowledge and personality profile pf patients on prescribed benzodiazepine.
 		 12 months  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/11/2024 
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="2"
Months="0"
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   The study aims to study the benzodizepine prespcrition pattern and dependance among psychiatric outpatients on prescribed benzodiazepine over long term.Secondary objectives include to determine the clinico demographic correlates and risk factors for developing benzodiazepine dependance and asses the awareness,knowledge and personality profile of patients on prescribed benzodiazepines.This study is conducted in Jawaharlal Nehru Medical College ,AMU,Aligarh U.P psychiatric outpatients over 2 years. 
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