Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder

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

Detailed Description
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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.

Official Title
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Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder

Conditions
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Vitamin b6 Level & Depression

Intervention / Treatment
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* Other: measure vitamin b6 in serum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 . Exclusion Criteria: Patients have Comorbidity with other psychiatric disorders . Patients have chronic medical conditions , chronic debilitating or nutritional disorders . for control , Patients with any psychiatric disorders .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| major depressive disorder patients<br>patient diagnosed with major depression for first time | Other: measure vitamin b6 in serum<br>* Vitamin B6 levels can be determined by using Enzyme- linked Immuno-sorbent Assay Kit For vitamin B6 . or Chemiluminescence Immunoassays (CLIA) . Venous blood samples will be taken from each patient. Use a serum separator tube and allow samples to clot for 10-20 minutes at room temperature and then centrifuged for 20 minutes at speed of 2000-3000 rpm (round per minute). Remove supernatant, if precipitation appeared, Centrifuge again. Extract as soon as possible after Samples collection, and should be tested as soon as possible after the extraction. If not, samples must be stored in aliquot at -20°C (≤ 1 month) or -80°C (≤ 2 months) to avoid loss of bioactivity and contamination. Hemolyzed Sample will be avoided , as hemolysis will interfere with the results .<br>|
| depression free persons<br>healthy persons | Other: measure vitamin b6 in serum<br>* Vitamin B6 levels can be determined by using Enzyme- linked Immuno-sorbent Assay Kit For vitamin B6 . or Chemiluminescence Immunoassays (CLIA) . Venous blood samples will be taken from each patient. Use a serum separator tube and allow samples to clot for 10-20 minutes at room temperature and then centrifuged for 20 minutes at speed of 2000-3000 rpm (round per minute). Remove supernatant, if precipitation appeared, Centrifuge again. Extract as soon as possible after Samples collection, and should be tested as soon as possible after the extraction. If not, samples must be stored in aliquot at -20°C (≤ 1 month) or -80°C (≤ 2 months) to avoid loss of bioactivity and contamination. Hemolyzed Sample will be avoided , as hemolysis will interfere with the results .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assesment of vitamin B6 level in patients with Major Depressive Disorder | Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease | baseline |