The Effects of High-dose Vitamin B6 on Depression and Anxiety Symptoms

University of Reading

Status: Enrolling

Conditions: Neural Inhibition; Depression; Anxiety

Treatments: Drug: Pyridoxal-5'-Phosphate supplement; Drug: Placebo Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT07469462

UREC25_13

Details and patient eligibility

About

This clinical trial investigates the effects of Vitamin B6 supplementation on neural inhibition using electroencephalography (EEG), in relation to depression and anxiety symptoms in participants from the general population with a relatively high level of symptoms at baseline. Researchers will compare a placebo group to high-dose Vitamin B6 to test the hypothesis that Vitamin B6 moves the excitation/inhibition balance towards inhibition.

Full description

The primary question this trial aims to answer is:

- Compared to placebo, in people experiencing depression and anxiety symptoms, does high-dose Vitamin B6 supplementation change the excitation/inhibition balance towards inhibition as measured using electroencephalography (EEG)?

Secondary research questions are:

• Compared to placebo, does high-dose Vitamin B6 supplementation reduce symptoms of depression and anxiety?
• Do individuals with lower Vitamin B6 levels at baseline, as measured in blood plasma, show a larger effect of high dose Vitamin B6 on the EEG measures or symptoms?
• Compared to placebo, does high-dose Vitamin B6 intervention lead to an increase in hand grip strength? This is a possibility suggested to us by our prvious finding of reduced self reported 'postural disorder' by Vitamin B6 (Field et al., 2024), and by existing literature about the role of Vitamin B6 in muscle function.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 41 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over 18 years of age and under 41
• Mild to moderate anxiety and/or depression
• Normal or corrected to normal vision

Exclusion criteria

• not taking daily dietary supplement containing >2 mg Vitamin B6
• not taking medication that is a GABA agaonist (our team will check this with you)
• not be pregnant
• no medical history of epilepsy
• no medical history of peripheral neuropathy
• not taking the antibiotic Seromycin (prescribed for tuberclosis or urinary tract infection)
• no history of brain injury or recent concussion

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Pyridoxal-5'-Phosphate supplement

Experimental group

Description:

100mg Vitamin B6 as pyridoxal-5-phosphate, daily with food

Treatment:

Drug: Pyridoxal-5'-Phosphate supplement

Microcrystalline Cellulose Placebo

Placebo Comparator group

Description:

Placebo capsule, daily with food

Treatment:

Drug: Placebo Supplementation