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Could an epilepsy drug quiet the overactive brain region behind psychosis?

NCT ID NCT06224530

Disease control Sponsor: King's College London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether a single dose of levetiracetam, a drug used for epilepsy, can reduce overactivity in the hippocampus — a brain area linked to thinking and memory problems in psychosis. People aged 18–40 who are at risk of psychosis will take either the drug or a placebo before undergoing MRI scans that measure blood flow, brain activity, and chemical levels. The study also includes healthy volunteers for comparison. The goal is to see if rebalancing brain signals could lead to new early treatments for psychosis.

What this could mean

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

Active substance
levetiracetam (an epilepsy medication) given as a single 500 mg dose, compared with a placebo
What this could lead to
If it works, this could point toward a new early treatment for psychosis that targets brain overactivity rather than dopamine, potentially helping with thinking and memory.
What could go wrong
This is an early, small study with a single dose, so any effects may be short-lived or not translate into long-term benefit. Levetiracetam can cause side effects like dizziness and sleepiness.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 69 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 40 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.

CHR-P inclusion criteria 1. Age range 18-40 years 2. Capacity to consent to participation in the study 3. Inclusion into attenuated psychosis group as assessed by the CAARMS 4. Scores 3-5 on CAARMS unusual thought content or non-bizarre ideas subscales CHR-P exclusion criteria: 1. Past episode of psychosis 2. Current exposure to drugs with strong GABAergic or glutamatergic effects (benzodiazepines, anticonvulsants, mood stabilisers, zopiclone, zolpidem, ketamine, opiates, atomoxetine, memantine) 3. Current/recent exposure to any antipsychotic medication 4. Diagnosis of any neurological disorder, including epilepsy 5. Current pregnancy/breastfeeding 6. Severe renal impairment 7. Known allergy to levetiracetam 8. Contraindication to MRI scanning 9. IQ\<70 as determined with WAIS-III 10. CHR-P individuals are not deemed to have a full-blown mental health disorder. However, in the event that a CHR-P individual is acutely ill and lacking capacity to consent, they will not be approached to take part in this study. HC inclusion criteria 1. Age range 18-40 years 2. Capacity to consent to participation in the study HC exclusion criteria: 1. Personal history of mental health conditions 2. Any first-degree relative with a psychotic disorder 3. Diagnosis of any neurological disorder, including epilepsy 4. Currently pregnant, breastfeeding, or trying to conceive 5. Current exposure to drugs with strong GABAergic or glutamatergic effects (benzodiazepines, anticonvulsants, mood stabilisers, zopiclone, zolpidem, ketamine, opiates, atomoxetine, memantine) 6. Current/recent exposure to any antipsychotic medication 7. Contraindication to MRI scanning 8. IQ\<70 as determined with WAIS-III

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Conditions

The condition(s) this trial relates to.

psychotic disorder Psychotic Disorders

As listed by the trial registrant

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

Psychosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Psychiatry, Psychology and Neuroscience, King's College London

    RECRUITING

    London, London, SE5 8AF, United Kingdom

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