跳至主要内容
临床试验/CTRI/2024/05/066905
CTRI/2024/05/066905尚未招募不适用

Serum 25-Hydroxyvitamin D levels and thyroid function tests in patients with Generalized Anxiety Disorder and Depressive Disorder

University college of medical sciences and Guru Teg Bahadur Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月25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
60
试验地点
1
主要终点
Serum 25-hydroxyvitamin D levels in patients with Generalized Anxiety Disorder and

研究概览

简要总结

Anxiety disorders are the most common type of mental health problems and comprise of a range of disorders, the most common being Generalized Anxiety Disorder (GAD). Depression is a prevalent clinical condition identified by a lasting and significant low mood, featuring periods of diminished interest, slowed cognitive processes, and decreased voluntary engagement. Thyroid dysfunction has been acknowledged for its substantial impact on mental health, potentially giving rise to disruptions in both emotional well-being and cognitive function. Vitamin D possesses neuroprotective properties, influencing the synthesis of neuromediators, the production and release of neurotrophins, maintaining intracellular calcium homeostasis, and safeguarding nervous tissue from oxidative damage. Most studies examining the correlations between vitamin D and anxiety symptoms have involved a diverse population- healthy adults, patients hospitalized for severe depression and those with medical conditions, but there are few studies which have been done in patients with a primary anxiety disorder. While the role of thyroid hormones has been established in depression, contradicting results have been seen in anxiety disorders. There is a paucity of research on the association of vitamin D and thyroid hormones in patients with GAD. There are very few comparisons of these parameters in patients with GAD and depressive disorder done, and hardly any have been done in patients attending a tertiary care hospital in the Indian Subcontinent.

Patients fulfilling inclusion and exclusion criteria will be taken for the study. Minimum 60 patients will be enrolled for the same. They will be evaluated with the following

scales: Hamilton Rating Scale for Anxiety (HAM-A) will be used to clinically evaluate the patients and rate severity of anxiety symptoms, Hamilton Rating Scale for Depression (HAM-D) will be used to clinically evaluate the patients and rate severity of depressive symptoms, Depression, Anxiety and Stress Scale (DASS-21) will be used to screen patients for depression, anxiety and stress. Blood samples will be

collected for 25-hydroxyvitamin D levels and thyroid function test (fT3, fT4, TSH). Reports of CBC, LFT, KFT, fasting blood glucose and lipid profile (T.Ch, TG, HDL) will be noted from hospital records.

All data will be included with a study ID number and strict confidentiality will be maintained. Statistical analysis and comparison of data will be done using SPSS. Comparison of serum 25-hydroxyvitamin D levels and thyroid function tests will be done by parametric and non-parametric statistical tests, depending upon the nature of the data being normal or skewed Correlation of serum 25-hydroxyvitamin D levels and thyroid function tests with severity of anxiety and depression will be done by Pearson’s correlation coefficient.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with age between 18-60 years.
  • Patient must meet criteria for: Either Primary diagnosis of Generalized Anxiety Disorder according to ICD-10 (The ICD-10 Classification of Mental and Behavioural Disorders) [Annexure 1] OR Primary diagnosis of Depressive episode- Mild, moderate or severe, or Recurrent Depressive Disorder according to ICD-10 (The ICD-10 Classification of Mental and Behavioural Disorders) [Annexure 2]
  • Patients should be able to read Hindi/English.

排除标准

  • Lifetime ICD-10 diagnosis of schizophrenia, schizoaffective or bipolar disorders.
  • Patients previously diagnosed with and undergoing treatment for any significant or chronic medical illness which alters vitamin D or thyroid hormone levels (renal disease, thyroid dysfunction, hepatic disease)
  • Patients consuming vitamin D supplements in the last 6 months.
  • Pregnant or lactating women.
  • Patients with substance dependence of alcohol and illicit substances (except nicotine).
  • Patients not consenting for participation in the study or for giving blood sample.

结局指标

主要结局

Serum 25-hydroxyvitamin D levels in patients with Generalized Anxiety Disorder and

时间窗: 1 week

Depressive Disorder

时间窗: 1 week

次要结局

  • 1. To evaluate thyroid function tests in patients of Generalized Anxiety Disorder and Depressive Disorder.(2. To study the correlation of serum levels of 25-hydroxyvitamin D and thyroid function tests with severity of anxiety, if any.)

研究者

发起方
University college of medical sciences and Guru Teg Bahadur Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Nikhita Loomba

University College of medical sciences and Guru Teg Bahadur Hospital

研究点 (1)

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