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CTRI Number  CTRI/2021/07/035041 [Registered on: 22/07/2021] Trial Registered Prospectively
Last Modified On: 25/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of understanding of treatment, prescribed medicines, side effects and obedience in patients of Depression. 
Scientific Title of Study   Evaluation of awareness of drug treatment, prescription pattern, adverse drug reactions and adherence in patients of Major Depressive Disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pranali Puradkar 
Designation  Junior Resident  
Affiliation  Seth GS Medical College 
Address  KEM hospital, Department of Pharmacology and Therapeutics Acharya Dhonde Marg, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  09833296746  
Fax    
Email  pranalipuradkar26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pranali Puradkar 
Designation  Junior Resident  
Affiliation  Seth GS Medical College 
Address  KEM hospital, Department of Pharmacology and Therapeutics Acharya Dhonde Marg, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  09833296746  
Fax    
Email  pranalipuradkar26@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pranali Puradkar 
Designation  Junior Resident  
Affiliation  Seth GS Medical College 
Address  KEM Hospital, Department of Pharmacology and Therapeutics, Acharya Donde Marg, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  09833296746  
Fax    
Email  pranalipuradkar26@gmail.com  
 
Source of Monetary or Material Support  
KEM hospital and Seth GS Medical College.  
 
Primary Sponsor  
Name  None 
Address  None 
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 
URWASHI PARMAR  KEM HOSPITAL  Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 		 9892406877

drurwashi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC)-III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.All patients with age 18-65 years, attending Psychiatry OPD for existing major Depressive Disorder diagnosed as per the DSM-V Criteria

2. Patients carrying treatment records prescribed at Psychiatry OPD of KEM hospital, containing antipsychotic medication regimen for at least 3 months.

 
 
ExclusionCriteria 
Details  1.Patients admitted in psychiatry IPD and emergency department

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, sensory impairment, and other psychiatric disorders such as mood disorders, and anxiety disorders.

5.Critically ill patients requiring urgent attention for medical problems

6. Severely agitated patients or with active suicidal ideation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NA  NA 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   26/07/2021 
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="6"
Days="2" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Title

Evaluation of awareness of drug treatment, prescription pattern, adverse drug reactions and adherence in patients of Major Depressive Disorder.

Primary Objective:

To assess the awareness of drug treatment in patients.

 Secondary Objectives:

 

1.To study the prescription pattern of the treatment of Major Depressive Disorder in Psychiatry OPD of Seth G.S. Medical College.

 

2.To assess the type, causality, severity, and preventability of ADRs in depressed patients being treated with antidepressants.

   3.To assess the adherence of patients to antidepressant medications

Methodology

 Study Design: A a cross-sectional, observational, single-center, questionnaire-based study

Study Site: Psychiatry OPD of Seth G.S. Medical College & KEMH, Mumbai.

 Study Duration: 18 months after Ethics Committee approval including data collection, analysis and report writing.

 Sample size: 150 to 200 patients will be enrolled in the study from January 2021 to June 2022.

 Ethics: Permission of the Institutional Ethics committee will be taken before beginning the study.

 Selection Criteria

Inclusion criteria for patients:

1.All patients with age 18-65 years, attending Psychiatry OPD for existing major Depressive Disorder diagnosed as per the DSM-V Criteria.

2.Patients carrying treatment records prescribed at Psychiatry OPD of KEM hospital, containing antidepressant medication regimen for at least 3 months.

  Exclusion Criteria for patients:

1.Patients admitted in psychiatry IPD and emergency department

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

5.Critically ill patients requiring urgent attention for medical problems

6. Severely agitated patients or with active suicidal ideation.

5. Variables to be measured

Primary Objective: To study the awareness of drug treatment in Major Depressive Disorder using an awareness questionnaire.

Secondary Objective :

1: To study the prescription pattern of treatment of Major Depressive Disorder in tertiary health care hospital

 2: ADRs

      1.Percentage of ADRs causally related to antidepressant treatment using the WHO- UMC

     2.Percentage of ADRs classified as mild, moderate, or severe, according to Hartwig-Siegel scale

3.Percentage of ADRs which are preventable, according to Schumock and Thorton scale

3:Adherence is assessed with the help of Morisky’s 8 item Medication Adherence Questionnaire.

STATISTICAL ANALYSIS

·        Categorical data will be expressed as a percentage.

·        Continuous variables will be presented as mean ± standard deviation (SD).

·        Variables of the prescription pattern will be analyzed using descriptive statistics and the level of drug utilization will be calculated using PDD/DDD ratio. 

·        Pearson’s correlation test will be used to assess the correlation between awareness and adherence to therapy.

 

 
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