Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder

Not yet recruiting

• Conditions: Vitamin b6 Level & Depression
• Interventions: Other: measure vitamin b6 in serum

• Registration Number: NCT05649293
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-26
• Last Update Posted: 2023-03-28
• Study Start: 2023-04-01
• Primary Completion: 2026-02
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• All participants must fulfill the following inclusion criteria;

  1. Patients diagnosed newly as major depressive disorder according to DSM-5( Diagnostic and Statistical Manual ) and (APA 2013) .
  2. Aged at least 18 years of both sex .
  3. Able to give informed consent .

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
major depressive disorder patients	measure vitamin b6 in serum	patient diagnosed with major depression for first time
depression free persons	measure vitamin b6 in serum	healthy persons

Primary Outcome Measures

Name	Time	Method
Assesment of vitamin B6 level in patients with Major Depressive Disorder	baseline	Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease