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

April 27, 2026 updated by: David Field, University of Reading

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pyridoxal-5'-Phosphate supplement
100mg Vitamin B6 as pyridoxal-5-phosphate, daily with food
Drug: Pyridoxal-5'-Phosphate supplement
100mg PLP in the form of a tablet, taken once a day for 1 week
Placebo Comparator: Microcrystalline Cellulose Placebo
Placebo capsule, daily with food
Drug: Placebo Supplementation
Placebo supplement in the form of a capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neural inhibition measured using Electroencephalography
Time Frame: From enrolment to the end of treatment 1 week later
From enrolment to the end of treatment 1 week later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported depression symptoms (Depression, Anxiety, and Stress questionnire, DASS)
Time Frame: From enrolment to the end of treatment 1 week later
From enrolment to the end of treatment 1 week later
Self reported anxiety (Screen for Adult Anxiety Related Disorders, SCAARED)
Time Frame: From enrolment to the end of treatment 1 week later
From enrolment to the end of treatment 1 week later
Hand grip strength
Time Frame: From enrolment to the end of treatment 1 week later
From enrolment to the end of treatment 1 week later
Vitamin B6 status
Time Frame: From enrolment to the end of treatment 1 week later
We will quantify Vitamin B6 in capillary blood samples
From enrolment to the end of treatment 1 week later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

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

Investigators

  • Principal Investigator: David T Field, University of Reading

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UREC25_13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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