Trials / Unknown
UnknownNCT05548075
Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Imperial College London · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess brain activity under Psilocybin in a cohort of people with fibromyalgia.
Detailed description
This mechanistic (Non-CTIMP) study will utilise a within-subjects design to examine a candidate brain biomarker of increased plasticity under Psilocybin. Up to 25mg of Psilocybin will be administered under standardised conditions on two occasions, separated by four weeks with in-dosing EEG recordings. The primary end-point will take place 8 weeks from the first dosing session after which patients will be remotely monitored monthly for 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Psilocybin | Up to 25mg of Psilocybin on 2 occasions. |
| BEHAVIORAL | Therapeutic support | Psychological and physical therapeutic support |
Timeline
- Start date
- 2022-08-15
- Primary completion
- 2024-01-10
- Completion
- 2024-07-30
- First posted
- 2022-09-21
- Last updated
- 2024-01-19
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05548075. Inclusion in this directory is not an endorsement.