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Psilocybin brain scan study aims to unlock new treatments

NCT ID NCT07050368

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 trial tested multiple doses of MLS101, a low-dose psilocybin capsule, in 20 healthy volunteers. Researchers used brain scans (fMRI) to see how the drug affects brain activity, while also checking safety and how the body processes the drug. The goal is to gather information that could support future treatments for neurological and psychiatric conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Psilocybin
What this could lead to
If successful, this study could help develop low-dose psilocybin as a treatment for neurological and psychiatric conditions.
What could go wrong
This is an early-phase trial in only 20 healthy people, so results may not apply to patients. Side effects are possible, and the drug may not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Jul 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males or females aged 18 to 55 years old (inclusive) at the time of signing the informed consent form. * Standard contraception measures are required for this clinical trial. * Healthy, in the opinion of the Investigator, based on prior (history of) or current (ongoing) medical and psychiatric screening assessments. * Participants with no clinically significant findings on physical examination, laboratory tests, and cardiac assessment. * Body mass index (BMI) within the range 18-32 kg/m2, inclusive. * Normal blood pressure. * Willing to not operate heavy machinery, including driving a vehicle at least 36 hours post Day 1 dose administration and 24 hours post all other dose administrations. * Capable of giving signed informed consent which includes the requirements and restrictions as per the approved study protocol Exclusion Criteria: * Prior known exposure to psilocybin, LSD, ayahuasca, N, N-Dimethyltryptamine, and related tryptamines, within the past 5 years. * Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease. * History of non-hospitalized but medicated Major Depressive Disorder (MDD), Generalized Anxiety Disorder or Panic Disorder ≤ 5 years prior to Screening. * History of or presence of cardiovascular disease. * Abnormal and clinically significant ECG. * Known personal or family history of congenital long QT syndrome or sudden death. * Current or a history of orthostatic hypotension or postural orthostatic tachycardic syndrome, multiple syncopes, or unresolved/ongoing clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness. * History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease or other behavioral disturbances resulting from other neurological disorders. * Use of medications that have CNS effects or affect performance. * Use of medications with serotonergic activity. * History or presence of hypersensitivity or idiosyncratic reaction to psilocybin or related compounds or microcrystalline cellulose * History of substance or alcohol abuse disorder in the last 10 years. * Participant who, for any reason, is deemed by the Investigator to be inappropriate for this study. * Contraindications to magnetic resonance imaging (MRI) or fMRI.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hammersmith Medicines Research (HMR)

    London, NW10 7EW, United Kingdom

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