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临床试验/NCT05649293
NCT05649293尚未招募不适用

Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder

Assiut University0 个研究点目标入组 94 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
94
主要终点
Assesment of vitamin B6 level in patients with Major Depressive Disorder

研究概览

简要总结

Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease

详细描述

Major depressive disorder (MDD) is a chronic health condition with significant consequences for health care costs, disability, quality of life, medical morbidity, and mortality. The World Health Organization (WHO) has considered depression as the leading cause of disability, a major contributor to overall global burden of disease . The core symptoms of depression are low mood and loss of interest or enjoyment in usually pleasurable activities. Associated symptoms include disturbances to sleep and appetite, reduced energy and concentration, negative thoughts of guilt or worthlessness and suicidal ideation. The International Statistical Classification of Diseases & Related Health Problems (ICD-10) states that for a diagnosis of depression at least five symptoms need to be present, including at least one of the core symptoms, at an intensity that causes functional impairment and for a minimum duration of 2 weeks.

Vitamin B6 (Pyridoxine) is a water-soluble compound that comprises three different pyridine derivatives, pyridoxine, pyridoxal, and pyridoxamine, of which PLP(pyridoxal phosphate) is the biologically most active form. The coenzyme PLP is an essential cofactor for amino acid decarboxylases involved in the synthesis of neurotransmitters implicated in depression, including dopamine, norepinephrine ,serotonin or 5-hydroxytryptamine (5-HT), and γ-amino butyric acid (GABA). it prevents the accumulation of neurotoxic intermediates produced during tryptophan metabolism, acting as a cofactor in the metabolism of tryptophan through the kynurenine aminotransferase and kynureninase enzymes. Inadequate intake of vitamin B6 has recently been linked to an increased risk of anxiety and depression in a cross-sectional study of over 3,000 individuals.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All participants must fulfill the following inclusion criteria;
  • •Patients diagnosed newly as major depressive disorder according to DSM-5( Diagnostic and Statistical Manual ) and (APA 2013) .
  • •Aged at least 18 years of both sex .
  • •Able to give informed consent .

排除标准

  • •Patients have Comorbidity with other psychiatric disorders .
  • •Patients have chronic medical conditions , chronic debilitating or nutritional disorders .
  • •for control , Patients with any psychiatric disorders .

结局指标

主要结局

Assesment of vitamin B6 level in patients with Major Depressive Disorder

时间窗: baseline

Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omnia Abd El Nasser Badry

doctor

Assiut University

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