NCT07469462

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
May 2026Nov 2026

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

March 9, 2026

Last Update Submit

April 27, 2026

Conditions

DepressionNeural InhibitionAnxiety

Keywords

Vitamin B6Excitation-Inhibition BalanceGABAElectroencephalograpgyDepressionAnxiety

Outcome Measures

Primary Outcomes (1)

  • Neural inhibition measured using Electroencephalography

    From enrolment to the end of treatment 1 week later

Secondary Outcomes (4)

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

    From enrolment to the end of treatment 1 week later

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

    From enrolment to the end of treatment 1 week later

  • Hand grip strength

    From enrolment to the end of treatment 1 week later

  • Vitamin B6 status

    From enrolment to the end of treatment 1 week later

Study Arms (2)

Pyridoxal-5'-Phosphate supplement

EXPERIMENTAL

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

Drug: Pyridoxal-5'-Phosphate supplement

Microcrystalline Cellulose Placebo

PLACEBO COMPARATOR

Placebo capsule, daily with food

Drug: Placebo Supplementation

Interventions

Placebo SupplementationDRUG

Placebo supplement in the form of a capsule.

Microcrystalline Cellulose Placebo
Pyridoxal-5'-Phosphate supplementDRUG

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

Pyridoxal-5'-Phosphate supplement

Eligibility Criteria

Age18 Years - 41 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harry Pitt Building

Reading, England, RG6 6ES, United Kingdom

RECRUITING

Related Publications (1)

  • Field DT, Cracknell RO, Eastwood JR, Scarfe P, Williams CM, Zheng Y, Tavassoli T. High-dose Vitamin B6 supplementation reduces anxiety and strengthens visual surround suppression. Hum Psychopharmacol. 2022 Nov;37(6):e2852. doi: 10.1002/hup.2852. Epub 2022 Jul 19.

    PMID: 35851507BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • David T Field

    University of Reading

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Cameron

CONTACT

0118 378 6803a.cameron@pgr.reading.ac.uk

David T Field

CONTACT

+44 1183785004d.t.field@reading.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

GB(1)