Clinical trial NCT05649293: Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder
Official title: Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vitamin b6 Level & Depression
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 94 participants divided into 47 patients diagnosed with major depressive disorder and 47 of normal population as control.

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Assesment of vitamin B6 level in patients with Major Depressive Disorder
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed A Abdel Rahman, Prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Romany H Gabra, dr
role: STUDY_DIRECTOR
References:
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citation: Arevalo SP, Scott TM, Falcon LM, Tucker KL. Vitamin B-6 and depressive symptomatology, over time, in older Latino adults. Nutr Neurosci. 2019 Sep;22(9):625-636. doi: 10.1080/1028415X.2017.1422904. Epub 2018 Jan 16.
citation: Moore K, Hughes CF, Hoey L, Ward M, Cunningham C, Molloy AM, Strain JJ, McCarroll K, Casey MC, Tracey F, Laird E, O'Kane M, McNulty H. B-vitamins in Relation to Depression in Older Adults Over 60 Years of Age: The Trinity Ulster Department of Agriculture (TUDA) Cohort Study. J Am Med Dir Assoc. 2019 May;20(5):551-557.e1. doi: 10.1016/j.jamda.2018.11.031. Epub 2019 Jan 25.