Effect of Levetiracetam on Brain Function and Cognitive Performance in Psychosis Risk
Investigating the Effect of a Single-dose of Levetiracetam on Brain Function, Chemistry and Cognitive Performance in Psychosis Risk
This study is testing if a single dose of levetiracetam can improve brain function and thinking skills in people at high risk for developing psychosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London, London) |
| Trial ID | NCT06224530 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-40 who are at clinical high risk for psychosis and exhibit specific positive symptoms.
Not a fit: Patients with a history of psychosis, current neurological disorders, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for individuals at risk of developing psychosis, potentially improving cognitive function and overall mental health.
How similar studies have performed: Previous studies have shown hippocampal hyperactivity in similar populations, suggesting that this approach may yield valuable insights, although the specific use of levetiracetam in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London, London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.