Menu
Recruiting NCT07469462

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

No phase Interventional Neural Inhibition Anxiety Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pyridoxal-5'-Phosphate supplement, Placebo Supplementation.
Who it may be relevant to
Registry conditions: Neural Inhibition, Anxiety, Depression. Basic parameters: 18 years — 41 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Drug Pyridoxal-5'-Phosphate supplement
    100mg PLP in the form of a tablet, taken once a day for 1 week
  • Drug Placebo Supplementation
    Placebo supplement in the form of a capsule.

Primary outcome measures

  • Neural inhibition measured using Electroencephalography [Time frame: From enrolment to the end of treatment 1 week later]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United Kingdom · 1 center
  • Harry Pitt Building — Reading

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. PMID 35851507

Identifiers

NCT: NCT07469462 · UREC25_13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗