| 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
|
|
|
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
|
|
|
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-Ã -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. |