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CTRI Number  CTRI/2024/07/071402 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Retinal nerve fibre layer ki thickness ka use as a biomarker for early detection of bipolar depression from uniplar depression 
Scientific Title of Study   Retinal nerve fibre layer thickness as a biomarker for early detection of bipolar depression from unipolar depression 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manpreet kaur virk 
Designation  Post-graduate student department of psychiatry rajindra hospital patiala 
Affiliation  Department of psychiatry government medical college rajindra hospital patiala  
Address  Department of psychiatry, room number 2, government medical college rajindra hospital patiala

Patiala
PUNJAB
147001
India 
Phone  8195892411  
Fax    
Email  mvirk5229@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajnish Raj 
Designation  Professor and Head Department of Psychiatry Government Medical college and Rajindra hospital Patiala 
Affiliation  Department of Psychiatry Government Medical college and Rajindra hospital Patiala 
Address  Department of Psychiatry, room number 1, Government Medical college and Rajindra hospital Patiala

Patiala
PUNJAB
147001
India 
Phone  9814913599  
Fax    
Email  profheadpsy@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajnish Raj 
Designation  Professor and Head Department of Psychiatry Government Medical college and Rajindra hospital Patiala 
Affiliation  Department of Psychiatry Government Medical college and Rajindra hospital Patiala 
Address  Department of Psychiatry, room number 1, Government Medical college and Rajindra hospital Patiala

Patiala
PUNJAB
147001
India 
Phone  9814913599  
Fax    
Email  profheadpsy@yahoo.com  
 
Source of Monetary or Material Support  
Government Medical College and Rajindra hospital patiala, punjab, pin code 147001 
 
Primary Sponsor  
Name  Manpreet Kaur Virk 
Address  Department of Psychiatry Rajindra Hospital patiala, punjab, pin code 147001 
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 Manpreet Kaur Virk  Government Medical college and Rajindra hospital Patiala  Department of Psychiatry, room number 2
Patiala
PUNJAB 
8195892411

mvirk5229@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Medical College Patiala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F31||Bipolar disorder, (2) ICD-10 Condition: F32||Major depressive disorder, singleepisode,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and Female patients aged 18-65 years who will be fulfilling DSM-5 criteria for bipolar affective disorder and unipolar depression.
2. Patients who will be medically stable.
3. Patients who will be giving written informed consent.
 
 
ExclusionCriteria 
Details  1. Previous or concurrent systemic disease (e.g., Hypertension, Diabetes mellitus) that may affect the eyes.
2. History of ophthalmological or neurological disease known to affect the visual pathway (e.g., Glaucoma, age-related macular degeneration, diabetic retinopathy, degenerative myopia).
3. Media opacification such as cataract, corneal leukoma, or vitreous haemorrhage that impede ocular and OCT examination.
4. History of traumatic head injury with loss of consciousness and seizures.
5. Drug or alcohol or Substance dependence.
6. Extremes of ages and other causes of bipolar disorders.
 
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the prevalence of RNFL thickness in patients of bipolar depression, unipolar depression compared to normal population.
To determine correlation of at-risk factors of socio-demographic variables, duration of illness and severity with RNFL thickness of bipolar depression, unipolar depression compared to normal population
To determine association and causality of factors for RNFL thickness in bipolar depression, unipolar depression compared to normal population
 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate prevalence of RNFL thickness in patients of bipolar depression, unipolar depression compared to normal population.
To determine correlation of at-risk factors of socio-demographic variables, duration of illness & severity with RNFL thickness of bipolar depression, unipolar depression compared to normal population
To determine association & causality of factors for RNFL thickness in bipolar depression, unipolar depression compared to normal population
 
Baseline 
 
Target Sample Size   Total Sample Size="225"
Sample Size from India="225" 
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)   15/08/2024 
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="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  

Bipolar disorder (BD) is defined by the presence of mania, hypomania, mixed or depression. Individuals with bipolar disorder spend more time in depression than mania or hypomania. The depressive episodes are more disabling than other mood states and are associated with increased mortality from suicide. Only 20% of BD receive a correct diagnosis if the index episode is depressive as it lacks differentiation from unipolar depression with a latency of 5 to 10 years. For early detection, alteration in the layers of the retina could serve as a biomarker since these originate from the same embryonic layer of the brain and are interconnected through the optic nerve. The aim of the study is to estimate the prevalence of Retinal nerve fibre (RNFL) changes in patients of bipolar depression (B-I, B-II); unipolar depression (UD) vis-à-vis normal population (age and gender-matched); to delineate any relationship or causality of RNFL changes with early onset, duration of illness or severity. It will be an analytic cross-sectional study. Patients will be taken from the outdoor Department of Psychiatry, G.M.C. and Rajindra Hospital, Patiala. The socio-demographic profile and other information will be recorded. For assessment of RNFL thickness on OCT, they will be referred to the Department of Ophthalmology. Data will be analysed by the relevant tests wherever applicable at statistically significant p-value ≤ 0.05.

 
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