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CTRI Number  CTRI/2024/01/062161 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 01/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Things that affect medication taking patterns in bipolar disorder patients in a tertiary care hospital in West Bengal 
Scientific Title of Study   Factors affecting medication adherence in bipolar disorder in a tertiary care hospital: a cross-sectional observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nadeem Chowdhury 
Designation  Post graduate trainee 
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Department of Pharmacology,244 AJC Bose Road, Kolkata
244 AJC Bose Road, Kolkata-20
Kolkata
WEST BENGAL
700020
India 
Phone  9800399253  
Fax    
Email  tungsten786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gairik Sengupta 
Designation  Associate Professor 
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Deptartment of Pharmacology Institute of postgraduate medical education and research 244 AJC BOSE ROAD

Kolkata
WEST BENGAL
700020
India 
Phone  9874621539  
Fax    
Email  drgairiksengupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nadeem Chowdhury 
Designation  Post graduate trainee 
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Department of Pharmacology 244 AJC Bose Road, Kolkata
244 AJC Bose Road, Kolkata-20
Kolkata
WEST BENGAL
700020
India 
Phone  9800399253  
Fax    
Email  tungsten786@gmail.com  
 
Source of Monetary or Material Support  
Institute of Postgraduate Medical Education and Research 
 
Primary Sponsor  
Name  Institute of Postgraduate Medical Education and Research 
Address  244 AJC Bose Road, Kolkata-20 
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 Nadeem Chowdhury  Institute of Postgraduate Medical Education and Research  Institute of Postgraduate Medical Education and Research, Department of Pharmacology, 244 AJC Bose Road Kolkata-20
Kolkata
WEST BENGAL 
9800399253

tungsten786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F317||Bipolar disorder, currently in remission,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed bipolar disorder patients as per ICD-10 criteria and under stable prescribed dose of medicines for the last 6 months and in clinical remission at the time of assessment  
 
ExclusionCriteria 
Details  Any acute illness likely to influence medication adherence
Patients in acute manic or depressed phase
Patients with other significant comorbidities including substance abuse except caffeine and nicotine 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the proportion of bipolar disorder patients adherent to their prescribed medication
To assess the factors influencing adherence to medication among these patients
 
1 year 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the attitudes of bipolar disorder patients about psychiatric medications
To assess the quality of life among bipolar disorder patients
To assess the need of counselling among these patients  
1 year 6 months  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   04/02/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

OBJECTIVES OF PROPOSED RESEARCH:

Primary objective: 

·       To assess the proportion of bipolar disorder patients adherent to their prescribed medication

·       To assess the factors influencing adherence to medication among these patients

 

Secondary objective:

 

·       To assess the attitudes of bipolar disorder patients about psychiatric medications

·       To assess the quality of life among these patients

·       To assess the need of counselling among these patients

 

BACKGROUND OF THE STUDY: Non-adherence in patients with bipolar disorder results in aggravation, bipolar disorder recurrence, emergency room visits, hospitalization, and poor psychosocial outcomes . Though non-adherence rates have been reported to range between 30-50% in patients with bipolar disorder , the problem of adherence is often either overlooked by the physician or denied by the patient. An essential first step to enhancing medication adherence is to objectively estimate adherence.    

METHODOLOGY: Bipolar disorder patients (diagnosed by ICD-10 criteria) under stable prescribed dose of medicines for 6 months and in clinical remission from the outpatient department will be recruited as per selection criteria.  Patients will be assessed using the following scales:

  • Morisky Medication Adherence Scale (MMAS)-8
  • Young Mania Rating Scale (YMRS)
  • WHO Quality of Life – BREF 
  • Drug Attitudes Inventory (DAI)-10

 

EXPECTED OUTCOME: Possible factors behind poor adherence identified in the study may assist in better understanding of patient behaviour regarding medication intake and suggest ways to improve therapeutic outcome in the long run. 


 
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