Status:
COMPLETED
R33: Levetiracetam in Early Psychosis
Lead Sponsor:
NYU Langone Health
Conditions:
Early Psychosis
Eligibility:
All Genders
16-40 years
Phase:
PHASE2
Brief Summary
This is a 12-week study of levetiracetam added to a second generation antipsychotic in early psychosis patients who have been ill for less than 5 years and continue to experience psychotic symptoms de...
Detailed Description
Participants will complete screening and baseline visits before being randomized in a 2:1 ratio to levetiracetam or placebo added to the antipsychotic medication. They will complete weekly study visit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04317807
Start Date
August 27 2020
End Date
April 10 2025
Last Update
October 31 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016