What side effects are associated with this type of intervention?

Second-generation antipsychotics, commonly used to treat schizophrenia, generally cause fewer extrapyramidal symptoms (EPS) such as akathisia, dystonia, and parkinsonism compared to first-generation antipsychotics. However, they can still lead to side effects like weight gain, metabolic syndrome, and sedation. First-generation antipsychotics, while effective, are more likely to cause EPS and tardive dyskinesia. Levetiracetam, an anti-epileptic drug being studied for its potential benefits in psychosis, can cause side effects such as dizziness, fatigue, and behavioral changes, but its use in schizophrenia is still under investigation.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, primarily focusing on second-generation antipsychotics such as aripiprazole, risperidone, olanzapine, and quetiapine. These drugs work by altering neurotransmitter activity, particularly dopamine and serotonin pathways, to manage symptoms of schizophrenia. While Levetiracetam, an anti-epileptic drug that alters neurotransmitter release, is being studied for its potential benefits in psychosis, it is not yet approved for schizophrenia treatment. Current approved treatments focus on managing neurotransmitter imbalances to reduce psychotic symptoms and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to Levetiracetam for schizophrenia patients in 2024 include second-generation antipsychotics such as aripiprazole, brexpiprazole, and cariprazine. These medications have shown efficacy in managing schizophrenia symptoms with potentially fewer side effects. Additionally, ongoing research into glutamate modulators and other neurotransmitter-targeting drugs may offer new treatment options.

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Anti-epileptic

Levetiracetam for Psychosis

Phase 2

Waitlist Available

Led By Stephan Heckers, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Age less than 18 or greater than 65

Not communicative in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours after placebo administration

Summary

This trial is testing whether levetiracetam, a common epilepsy medication, can reduce overactivity in a part of the brain called the hippocampus in people with psychotic disorders. The goal is to see if calming this brain area can help with their symptoms. Levetiracetam is a second-generation antiepileptic drug that is approved for clinical use and may also be used for additional treatment of patients with seizures.

Who is the study for?

This trial is for English-speaking adults aged 18-65 with a confirmed diagnosis of a psychotic disorder, such as schizophrenia. Participants must be physically healthy, have a stable medication regimen for at least two weeks, and not be pregnant or nursing. Women should use effective contraception during the study.

What is being tested?

The study tests if levetiracetam (LEV), an anti-epileptic drug, can reduce overactivity in the hippocampus of people with psychosis using MRI techniques. The goal is to understand how this brain region contributes to their symptoms.

What are the potential side effects?

While specific side effects are not listed here, LEV may generally cause dizziness, fatigue, coordination problems among others. Side effects from placebos are usually psychological due to expectations rather than the substance itself.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours after lev administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours after lev administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours after lev administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV)

Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo

Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, then Levetiracetam (LEV)Experimental Treatment2 Interventions

Participants will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day.

Group II: Levetiracetam (LEV), then PlaceboExperimental Treatment2 Interventions

Participants will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Levetiracetam (LEV) 500 mg

2020

Completed Phase 2

~70

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia primarily involve antipsychotic medications, which work by modulating neurotransmitter systems in the brain, particularly dopamine and serotonin pathways. Typical antipsychotics, like haloperidol, primarily block dopamine D2 receptors, reducing symptoms such as hallucinations and delusions. Atypical antipsychotics, such as risperidone and clozapine, target both dopamine and serotonin receptors, offering a broader spectrum of symptom control and often fewer side effects. Levetiracetam, an anti-epileptic drug being studied for schizophrenia, alters neurotransmitter release, which may help in reducing hippocampal hyperactivity associated with psychotic symptoms. Understanding these mechanisms is crucial for tailoring treatments to individual patients, potentially improving efficacy and reducing side effects.

[Diagnosis and treatment of motor phenomena in schizophrenia spectrum disorders].