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

RecruitingNAAges 18 Years - 40 YearsAllKing's College London
NCT06224530 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 medicati

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📋 Eligibility rules (as published)
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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What it tests

  • Levetiracetam
  • Placebo
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Where

1 site
Institute of Psychiatry, Psychology and Neuroscience, King's College London
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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