Effect of Levetiracetam on Brain Function and Cognitive Performance in Psychosis Risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how a single dose of levetiracetam, a medication commonly used for epilepsy, affects brain function and cognitive performance in individuals at clinical high risk for psychosis. Using a randomized, double-blind, placebo-controlled crossover design, 36 participants will receive both levetiracetam and a placebo during separate scanning visits. The study aims to assess changes in hippocampal activity, cognitive performance, and brain chemistry through neuroimaging techniques. By focusing on individuals with specific positive symptoms, the research seeks to understand the medication's potential to balance brain excitation and inhibition.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Gemma Modinos, BSc MSc PhD — King's College London
• Study coordinator: Abigail A Gee, MBChB MSc
• Email: abigail.gee@kcl.ac.uk

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.