Levetiracetam for Early Psychosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding levetiracetam, a drug typically used for epilepsy, can benefit individuals with early psychosis who continue to experience symptoms after using antipsychotic medications. The aim is to determine if levetiracetam can reduce these symptoms and prevent brain shrinkage. Participants will receive either levetiracetam or a placebo for 12 weeks. This trial suits individuals who have had nonaffective psychosis, such as schizophrenia, for less than five years and still experience symptoms despite taking antipsychotic drugs for at least eight weeks. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must have been on a stable dose of antipsychotic medication for at least 4 weeks before joining the study.
Is there any evidence suggesting that levetiracetam is likely to be safe for humans?
Research has shown that levetiracetam, a drug approved for treating epilepsy, is generally safe for use. Studies have found that most people tolerate it well, and it often works as effectively as other common epilepsy medications. However, about 0.7% of people might experience serious side effects such as hostility, depression, or agitation.
Since the FDA has approved levetiracetam for epilepsy, its safety is well-documented. This ensures that while researchers explore new uses, such as treating early psychosis, the basic safety of the drug is already established.
In summary, levetiracetam is usually safe but can cause serious side effects in a small number of cases.12345Why do researchers think this study treatment might be promising for early psychosis?
Researchers are excited about levetiracetam for early psychosis because it targets brain activity differently than standard antipsychotic medications. Most current treatments work by altering dopamine levels, but levetiracetam is believed to stabilize neural activity by modulating glutamate release, offering a fresh approach. This unique mechanism could lead to fewer side effects and potentially faster symptom relief, making it a promising alternative for those who don't respond well to existing therapies.
What evidence suggests that levetiracetam might be an effective treatment for early psychosis?
Research has shown that levetiracetam might help manage symptoms in people with schizophrenia by calming overactivity in the brain, particularly in the hippocampus, which can be overly active in schizophrenia. In this trial, participants in the study drug group will receive levetiracetam to assess its effects on early psychosis. One study found that levetiracetam had a significant positive effect on schizophrenia symptoms compared to other treatments. This suggests that adding levetiracetam to current antipsychotic medications might help those who still experience symptoms. Although some individuals taking levetiracetam have experienced severe psychiatric symptoms, the overall evidence suggests it could be beneficial for early psychosis.36789
Who Is on the Research Team?
Donald Goff
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for individuals aged 16-40 who have had a first episode of nonaffective psychosis within the last 5 years and still experience symptoms despite taking antipsychotics for at least 8 weeks. Participants must not be pregnant, nursing, or planning pregnancy and should agree to use birth control. Exclusions include substance abuse (except nicotine/THC), major mood disorders other than schizophrenia spectrum disorders, significant medical conditions, or contraindications to MRI.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments including cognitive testing and brain imaging
Treatment
Participants receive levetiracetam or placebo added to antipsychotic medication for 12 weeks
Tapering
Medication tapering regimen over 9 days after treatment phase
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Levetiracetam
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor