跳至主要内容
临床试验/CTRI/2024/07/071402
CTRI/2024/07/071402尚未招募不适用

Retinal nerve fibre layer thickness as a biomarker for early detection of bipolar depression from unipolar depression

Manpreet Kaur Virk1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
225
试验地点
1
主要终点
To estimate the prevalence of RNFL thickness in patients of bipolar depression, unipolar depression compared to normal population.

研究概览

简要总结

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 ofRNFL 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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Male and Female patients aged 18-65 years who will be fulfilling DSM-5 criteria for bipolar affective disorder and unipolar depression.
  • Patients who will be medically stable.
  • Patients who will be giving written informed consent.

排除标准

  • Previous or concurrent systemic disease (e.g., Hypertension, Diabetes mellitus) that may affect the eyes.
  • History of ophthalmological or neurological disease known to affect the visual pathway (e.g., Glaucoma, age-related macular degeneration, diabetic retinopathy, degenerative myopia).
  • Media opacification such as cataract, corneal leukoma, or vitreous haemorrhage that impede ocular and OCT examination.
  • History of traumatic head injury with loss of consciousness and seizures.
  • Drug or alcohol or Substance dependence.
  • Extremes of ages and other causes of bipolar disorders.

结局指标

主要结局

To estimate the prevalence of RNFL thickness in patients of bipolar depression, unipolar depression compared to normal population.

时间窗: Baseline

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

时间窗: Baseline

To determine association and causality of factors for RNFL thickness in bipolar depression, unipolar depression compared to normal population

时间窗: Baseline

次要结局

  • 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)

研究者

发起方
Manpreet Kaur Virk
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Manpreet kaur virk

Department of psychiatry government medical college rajindra hospital patiala

研究点 (1)

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