FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064196 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 23/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Post Stroke Depression and its Risk Factors 
Scientific Title of Study   Burden of Post Stroke Depression and Risk Factor Identification 
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 Parinitha Maben 
Designation  Junior Resident 
Affiliation  Father Muller Medical College & Hospital 
Address  Department of Psychiatry Father Muller Medical College and Hospital Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9008701157  
Fax    
Email  veenpari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharth Shetty 
Designation  Professor & Head of Unit 
Affiliation  Father Muller Medical College and Hospital Mangalore 
Address  Department of Psychiatry Father Muller Medical College and Hospital Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845036281  
Fax    
Email  siddharth.shetty@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Siddharth Shetty 
Designation  Professor & Head of Unit 
Affiliation  Father Muller Medical College and Hospital Mangalore 
Address  Department of Psychiatry Father Muller Medical College and Hospital Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845036281  
Fax    
Email  siddharth.shetty@gmail.com  
 
Source of Monetary or Material Support  
Father Muller Medical College and Hospital, Mangalore 
 
Primary Sponsor  
Name  Dr. Parinitha Maben 
Address  Department of Psychiatry Father Muller Medical College and Hospital Kankanady Mangalore 
Type of Sponsor  Other [Principal Investigator] 
 
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 Parinitha Maben  Father Muller Medical College and Hospital Mangalore  Neurology ward (N1) Second Floor Father Muller Hospital Kankanady Mangalore
Dakshina Kannada
KARNATAKA 		 9008701157

veenpari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I630||Cerebral infarction due to thrombosis of precerebral arteries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Male and female adult patients admitted with first or recurrent ischemic stroke with the most recent stroke within the past one month.  
 
ExclusionCriteria 
Details  Those patients in whom meaningful communication is impaired due to severe aphasia, cognitive impairment, hearing/visual impairment, those with past history of psychiatric illness and those with uncontrolled medical comorbidities and end stage organ failure. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnosis of post stroke depression as per ICD-10 criteria.  Diagnosis of post stroke depression as per ICD-10 criteria at least 2 weeks after the onset of stroke. 
 
Secondary Outcome  
Outcome  TimePoints 
Severity of post stroke depression as per ICD 10 diagnostic criteria.  Severity of post stroke depression as per ICD 10 diagnostic criteria at least 2 weeks after the onset of stroke. 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   07/02/2025 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [veenpari@gmail.com].

  6. For how long will this data be available start date provided 24-06-2024 and end date provided 24-06-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This cross-sectional observational study will be conducted among in-patients and out-patients of the Neurology department at Father Muller Medical College Hospital which is a multispecialty teaching hospital in Mangalore. It is a short study done as part of the post-graduate MD Psychiatry course.

Aim of the Study: To estimate the burden of post stroke depression (PSD) and identify its risk factors.
Objectives:
1. To estimate the prevalence and severity of post stroke depression in the acute phase following stroke.
2. To determine the factors contributing to the development post stroke depression.
3. To identify an association if any between inflammatory markers and PSD.
4. To identify an association if any between infarct location and PSD.

Sampling Method: Convenience (non-random) sampling.

Inclusion Criteria:
1. Individuals who have been diagnosed with first or recurrent ischemic stroke.
2. Patient with stroke within the past 3 months.
3. Age group: Above 18 years

Exclusion Criteria:
1. Patients with patients with impaired GCS, severe aphasia, cognitive impairment,
hearing/visual impairment interfering with meaningful communication.
2. Patients with past history of psychiatric disorder.
3. Patients with severe medical complications.

Method/study procedure:
The study will be conducted over a 3-month period after approval from the institutional scientific committee and ethics committee.
Written informed consent will be taken from each participant consenting to take part in the study. Participants will receive a patient information sheet explaining the study.
The investigator shall conduct face-to-face interviews with the study participants in the neurology wards at FMMCH, Mangalore.
Data will be collected in the form of a structured proforma, and using the instruments.
The Mini Mental Status Examination will be used to exclude patients with cognitive impairment.
All participants will be evaluated using the Post Stroke Depression Rating Scale (PSDRS) and The National Institutes of Health Stroke Scale (NIHSS).
MRI/CT brain done as part of diagnostic evaluation of stroke will be used to classify stroke lesion as left or right hemisphere, cortical or subcortical and size of infarct.
Hematological investigations done as part of stroke evaluation will be taken from hospital records to obtain values of inflammatory markers such as total WBC counts, ESR, RDW.
A structured proforma for sociodemographic data, clinical profile, stroke lesion location and duration of illness will be used.
 
Close