Neural InhibitionNCT07469462
The Effects of High-dose Vitamin B6 on Depression and Anxiety Symptoms
A study testing Pyridoxal-5'-Phosphate supplement in people with Neural Inhibition and Anxiety, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 41 yearsHealthy volunteers can take part
- Conditions the study is for
- Neural Inhibition, Anxiety, Depression
- What is being tested?
- Pyridoxal-5'-Phosphate supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 18 years of age and under 41
- Mild to moderate anxiety and/or depression
- Normal or corrected to normal vision
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Neural Inhibition, Anxiety, Depression
- Being tested
- Pyridoxal-5'-Phosphate supplement, Placebo Supplementation
- Keywords
- Vitamin B6, Excitation-Inhibition Balance, GABA, Electroencephalograpgy, Depression, Anxiety
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridoxal-5'-Phosphate supplementDrug
100mg PLP in the form of a tablet, taken once a day for 1 week
Placebo SupplementationDrug
Placebo supplement in the form of a capsule.
| Study group | Role | What they receive |
|---|---|---|
| Pyridoxal-5'-Phosphate supplement | Experimental | 100mg Vitamin B6 as pyridoxal-5-phosphate, daily with food Receives: Drug: Pyridoxal-5'-Phosphate supplement |
| Microcrystalline Cellulose Placebo | Placebo comparator | Placebo capsule, daily with food Receives: Drug: Placebo Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural inhibition measured using Electroencephalography
Measured: From enrolment to the end of treatment 1 week later
Secondary outcomes (4)
Self-reported depression symptoms (Depression, Anxiety, and Stress questionnire, DASS)
Measured: From enrolment to the end of treatment 1 week later
Self reported anxiety (Screen for Adult Anxiety Related Disorders, SCAARED)
Measured: From enrolment to the end of treatment 1 week later
Hand grip strength
Measured: From enrolment to the end of treatment 1 week later
Vitamin B6 status
We will quantify Vitamin B6 in capillary blood samples
Measured: From enrolment to the end of treatment 1 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start23 Mar 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neural InhibitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- INNOPURE
- Responsible party
- Principal investigator, David Field, University of Reading
- Investigators
- David T Field, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469462
- Sponsor's protocol ID
- UREC25_13
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An EEG Study to Investigate the Effect of High-dose Vitamin B6 Supplementation on Neural Activity in Relation to Depression and Anxiety Symptoms.
- ClinicalTrials.gov ID
- NCT07469462
- Acronym / sponsor ID
- UREC25_13
- Conditions
- Neural Inhibition, Anxiety, Depression
- Keywords
- Vitamin B6, Excitation-Inhibition Balance, GABA, Electroencephalograpgy, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- INNOPURE
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyridoxal-5'-Phosphate supplement | Experimental | Drug: Pyridoxal-5'-Phosphate supplement100mg Vitamin B6 as pyridoxal-5-phosphate, daily with food |
| Microcrystalline Cellulose Placebo | Placebo comparator | Drug: Placebo SupplementationPlacebo capsule, daily with food |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Over 18 years of age and under 41
- Mild to moderate anxiety and/or depression
- Normal or corrected to normal vision
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyridoxal-5'-Phosphate supplement100mg PLP in the form of a tablet, taken once a day for 1 week | Drug | Pyridoxal-5'-Phosphate supplement |
| Placebo SupplementationPlacebo supplement in the form of a capsule. | Drug | Microcrystalline Cellulose Placebo |
Primary outcome
Neural inhibition measured using Electroencephalography
Time frame: From enrolment to the end of treatment 1 week later
4 secondary outcomes
Self-reported depression symptoms (Depression, Anxiety, and Stress questionnire, DASS)
Time frame: 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
Hand grip strength
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 35851507Field 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David T Field principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyridoxal-5'-Phosphate supplement in people with Neural Inhibition and Anxiety, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural inhibition measured using Electroencephalography (time frame: From enrolment to the end of treatment 1 week later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07469462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.