R33: Levetiracetam in Early Psychosis

  • End date
    Sep 26, 2022
  • participants needed
  • sponsor
    NYU Langone Health
Updated on 26 January 2021


This is a 12 week study of Levetiracetam in conjunction with a second generation antipsychotic in medication-free first episode psychosis participants. Treatment with antipsychotics has been shown to be associated with loss of volume in the hippocampus. Brain chemicals, called neurotransmitters, that might be associated with this loss are glutamate and dopamine. The drug levetiracetam reduces excessive amounts of these neurotransmitters, which may help protect against this loss when taken with antipsychotics.


Participants will complete screening and baseline visits before being randomized in a 2:1 ratio of levetiracetam or placebo. They will complete weekly study visits for the first 4 weeks (Baseline, Weeks 2-4) and then additional visits at Week 6, 8, and 12. Participants will be studied both by assessing change in symptom severity and cognitive performance over the 12 weeks as well as using a measure of Hippocampal Volume Integrity at baseline and week 12. After completing Week 12 or decision to withdraw prematurely from the study, participants will complete a 9 day medication tapering regimen.

Condition Early Psychosis
Treatment Placebo, Levetiracetam Pill
Clinical Study IdentifierNCT04317807
SponsorNYU Langone Health
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age between 16 yrs and 35 yrs?
Gender: Male or Female
Do you have Early Psychosis?
Do you have any of these conditions: Do you have Early Psychosis??
Males and females 16 to 35 years of age, inclusive, at time of informed consent
Must have experienced a first episode of non affective psychosis within 5 years and exhibit current psychosis, as defined by a score of 2 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 DSMIV TR (SCID)
Must not have taken an oral antipsychotic medication within the past 4 weeks prior to study enrollment or received a long acting injectable antipsychotic within 3 times the dosing interval
If female and of childbearing potential, patients must
Have a negative urine pregnancy test (all females regardless of childbearing potential will be required to submit a pregnancy test)
Not be nursing or planning a pregnancy for the duration of the study through 30 days after the last dosing visit
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 non-THC substances, (i.e. alcohol, amphetamines, barbiturates)
A positive urine toxic screen (excluding THC or tricyclic antidepressants)
Moderate or severe cannabis use disorder
use of marijuana within the 72 hours prior to MRI scanning
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 and/or PhD or MD level clinician completing screening visit
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
Metal implants, pacemaker, or other metal in the body or medicinal patch
History of claustrophobia
Currently taking any antipsychotic medication (within 4 weeks)
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