ClinicalTrials.gg
CompletedNCT07469462Updated Oct 7, 2026

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

An interventional study of Pyridoxal-5'-Phosphate supplement and Placebo Supplementation in Neural Inhibition, Anxiety and Depression, sponsored by University of Reading. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 41 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.

Primary conditionDepressionRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Depression
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Depression.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Reading · Not applicable, Interventional, and Basic science

Updated Oct 7, 2026Now CompletedStart date moved+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 41 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Depression by University of Reading — 2 open to participants now, 3 under way, none of them phase 3. Depression · University of Reading.

Started
2026
with 2 others
No phase
9 of 10
2 open now
Registered
8th of 10
by date

Among the 10 studies in Depression by University of Reading, this one is one of 3 that started in 2026, is one of 9 with no phase, and was the 8th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

No phasethis study9 · 2 open
Observational1 · 0 open

By the year they started

First in 2017; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 55 across the 9 interventional studies, 318 across the 1 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies in Depression by University of Reading, or all of them as a file.
02

Study 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.

Read the 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.
03

Conditions studied

  • Neural Inhibition
  • Anxiety
  • Depression

Browse trials for

Keywords

  • Vitamin B6
  • Excitation-Inhibition Balance
  • GABA
  • Electroencephalograpgy
  • Depression
  • Anxiety
04

In context

Depression Reclassified

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's enrollment of 44 is below the median of 81 across 7,063 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Reading is the lead sponsor of 150 studies on the registry; 21 are open to participants now.

Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 41 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
06

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Pyridoxal-5'-Phosphate supplement

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

    Drug: Pyridoxal-5'-Phosphate supplement

  • Placebo comparator
    Microcrystalline Cellulose Placebo

    Placebo capsule, daily with food

    Drug: Placebo Supplementation

Interventions

  • DrugPyridoxal-5'-Phosphate supplement

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

  • DrugPlacebo Supplementation

    Placebo supplement in the form of a capsule.

07

What researchers measure

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

    We will quantify Vitamin B6 in capillary blood samples

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

08

Study locations

1 site
  • Harry Pitt Building
    Reading, England RG6 6ES, United Kingdom
09

References and documents

Publications

  • 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. PubMed 35851507 ↗

Individual participant data

Plan to share: Undecided

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2026 to primary completion in Sep 2026, 6 months.

Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 6 months is below that.

Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 7, 2026: start May 2026 → Mar 2026, primary completion Nov 2026 → Sep 2026 and completion Nov 2026 → Sep 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2026
First posted
Mar 13, 2026
StartActual
Mar 23, 2026was May 2026
Primary completionActual
Sep 30, 2026was Nov 2026
CompletionActual
Sep 30, 2026was Nov 2026
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 7, 2026
Start date
May 1, 2026→Mar 23, 2026 (actual)
Oct 7, 2026
Primary completion
Nov 2026→Sep 30, 2026 (actual)
Oct 7, 2026
Study completion
Nov 2026→Sep 30, 2026 (actual)
Oct 7, 2026
Sponsor
Collaborators added: INNOPURE; collaborators removed: eBeauty Ltd Innopure, Regus House, Cardiff Gate Business Park, Malthouse Avenue, Cardiff, CF23 8RU
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Recruiting→Completed
    Start date May 1, 2026→Mar 23, 2026 (now actual)
    Primary completion Nov 2026→Sep 30, 2026 (now actual)
    Study completion Nov 2026→Sep 30, 2026 (now actual)
    Sponsor Collaborators added: INNOPURE; collaborators removed: eBeauty Ltd Innopure, Regus House, Cardiff Gate Business Park, Malthouse Avenue, Cardiff, CF23 8RU
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT07469462
Collaborators
INNOPURE
Responsible party
David Field (Associate professor, University of Reading) — Principal investigator
First posted
Mar 13, 2026
Start date
Mar 23, 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026
Last update
Oct 7, 2026

Study contacts

David T Field
principal investigator · University of Reading

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion