Could an epilepsy drug ease stubborn psychosis?
NCT ID NCT04317807
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding levetiracetam (a seizure medication) to standard antipsychotics helps people with early psychosis who still have symptoms. 65 participants took either the drug or a placebo for 12 weeks. The goal was to see if it reduces psychotic symptoms and protects the brain from shrinkage.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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65 people
The number who actually took part.
- Started
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Aug 2020
- Finished
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Apr 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Males and females 16 to 40 years of age, inclusive, at time of informed consent * Must have experienced a first episode of nonaffective psychosis within 5 years and exhibit current psychosis, as defined by a score of ≥ 4 on one of the following psychosis items on the BPRS: conceptual disorganization, suspiciousness, hallucinations, unusual thought content, or grandiosity, for at least 4 days per week for at least 4 weeks * Must have a diagnosis of either schizophrenia, schizoaffective disorder or schizophreniform disorder as established by a Structured Clinical Interview for DSM-V (SCID) * Must have taken antipsychotic medication for a minimum of 8 weeks and at a stable dose for at least 4 weeks prior to randomization * If assigned female at birth and of childbearing potential, patients must: * Have a negative urine pregnancy test (all participants assigned female at birth regardless of childbearing potential will be required to submit a pregnancy test) and * Not be nursing or planning a pregnancy for the duration of the study through 30 days after the last dosing visit and * Be abstinent or willing to use a reliable method of birth control from the screening visit and continue with the same method until termination from the study Exclusion Criteria * Current substance abuse or dependence for substances other than nicotine and THC (i.e. alcohol, amphetamines, barbiturates) * A positive urine toxic screen (excluding THC, tricyclic antidepressants, or benzodiazepines (if prescribed)) * Moderate or severe cannabis use disorder * Diagnosis of major mood disorder or other Axis I disorder other than Schizophrenia, Schizoaffective Disorder or Schizophreniform Disorder * Current suicidal ideation. Suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the suicidal ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the Principal Investigator * Pregnant, nursing or positive urine pregnancy test * Significant medical or neurological illness by history or physical exam including seizure disorder, history of loss of consciousness related to head trauma or developmental disorder including mental retardation * Renal insufficiency (if serum creatinine is greater than laboratory limits for normal, estimated creatinine clearance must be greater than 80) * Contraindications to MRI: metal implants, pacemaker, or other metal in the body, or claustrophobia. Individuals with tattoos will be excluded from imaging if tattoos cover more than 5% of the body surface, if a tattoo is greater than 20 cm, or if the tattoo is located on the face, neck or genitals. (Individuals with a contraindication to MRI may participate in the trial but will be excluded from the elective MRI component) * Significant history of serious violence * For both inpatient and outpatient subjects, a history of serious violence as assessed by the Buss-Perry Aggression Questionnaire * For outpatient subjects only, a score of 5 (moderately severe) or higher on the BPRS hostility item at screening or baseline
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NYU Langone Health
New York, New York, 10016, United States
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Other studies related to the condition(s) this trial covers.
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