NCT06224530 Investigating the Effect of a Single-dose of Levetiracetam on Brain Function, Chemistry and Cognitive Performance in Psychosis Risk

Eligibility & Interventions

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This trial targets 69 participants in total. It began in 2024-07-19 with a primary completion date of 2026-02.

Brief Summary

Background Psychosis is a mental health condition that affects around 3 in 100 people in their lifetime. Most treatments for psychosis target a brain chemical called dopamine but they don't work for everyone and don't address many of the symptoms. People with psychosis and people at risk of developing psychosis show differences in a part of the brain called the hippocampus, such as smaller size and increased activity. This hyperactivity may be associated with cognitive difficulties (thinking and memory). The basis of this hippocampal hyperactivity is thought to be a deficit in excitation and inhibition of brain cells. Excitation causes brain cells to send signals more frequently, and inhibition causes cells to send signals less frequently. A balance between these signals is important for the brain, including the hippocampus, to function properly. Approach Levetiracetam is a medication that is widely used to treat epilepsy and which helps balance excitation-inhibition in the brain. We will use brain imaging, using Magnetic Resonance Imaging (MRI), to test if levetiracetam can help reduce hippocampal hyperactivity, alter connectivity and change levels of brain chemicals in people who are at risk of developing psychosis. Participants (18-40 years), identified as at risk of psychosis through the Outreach and Support in South London (OASIS) teams, will attend an initial visit at the Institute of Psychiatry, Psychology \& Neuroscience. This will involve questions about experiences and feelings, assessment of thinking and memory, and a blood test. They will then attend two scanning visits at the Centre for Neuroimaging Sciences, during which they will take capsules of either levetiracetam or placebo (in a randomised order) before having a 60 mins MRI scan. The MRI scan will look at blood flow to the hippocampus, resting activity, activity during a cognitive task and levels of brain chemicals. A case-control sample of 33 healthy individuals aged 18-40 will be recruited from Greater London. We will recruit a healthy control (HC) sample to establish the presence of hippocampal dysfunction in our CHR-P group by comparing the MRI data for CHR-P under the placebo condition with that of the HC sample. The HC individuals will attend the screening visit and one scanning visit. They will not receive any medication. Funded by the Wellcome Trust and conducted by King's College London researchers, the study spans 2-3 months per participant. Impact Our study will provide important evidence about how levetiracetam affects brain function, and how this relates to cognition. This knowledge may lead to innovative approaches for understanding and treating psychosis early.

Eligibility Criteria

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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