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NCT Number: NCT07469462

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

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.

Recruiting

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Key information

Age range

18 year–41 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harry Pitt Building

Reading, England, RG6 6ES, United Kingdom

Location status: Recruiting

Location contact

Alexander Cameron

CONTACT

[email protected]

07710555979

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pyridoxal-5'-Phosphate supplement

Drug

100mg PLP in the form of a tablet, taken once a day for 1 week

Placebo Supplementation

Drug

Placebo supplement in the form of a capsule.

Primary outcomes

  1. Neural inhibition measured using Electroencephalography

    Time frame: From enrolment to the end of treatment 1 week later

Secondary outcomes

  1. Self-reported depression symptoms (Depression, Anxiety, and Stress questionnire, DASS)

    Time frame: From enrolment to the end of treatment 1 week later

  2. Self reported anxiety (Screen for Adult Anxiety Related Disorders, SCAARED)

    Time frame: From enrolment to the end of treatment 1 week later

  3. Hand grip strength

    Time frame: From enrolment to the end of treatment 1 week later

  4. Vitamin B6 status

    Time frame: From enrolment to the end of treatment 1 week later

    We will quantify Vitamin B6 in capillary blood samples

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Cameron

CONTACT

[email protected]

0118 378 6803

David T Field

CONTACT

[email protected]

+44 1183785004

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • eBeauty Ltd Innopure, Regus House, Cardiff Gate Business Park, Malthouse Avenue, Cardiff, CF23 8RU

Registry information

Official study title

An EEG Study to Investigate the Effect of High-dose Vitamin B6 Supplementation on Neural Activity in Relation to Depression and Anxiety Symptoms.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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