Levetiracetam in Early Psychosis



Status:Recruiting
Conditions:Schizophrenia, Psychiatric, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:16 - 30
Updated:3/24/2019
Start Date:May 1, 2017
End Date:June 30, 2019
Contact:Michelle Worthington, MA
Email:michelle.worthington@nyumc.org
Phone:646 754 4803

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A Randomized, Double-blind, Placebo-controlled Trial Investigating the Effects of Levetiracetam in Early Psychosis

In order to establish target engagement and identify an effective dose the investigators will
conduct a placebo-controlled single-dose parallel group trial of levetiracetam 185 mg and 500
mg in 24 medication-naïve early psychosis (EP) patients, measuring hippocampal activity by
pulsed arterial spin labelling (ASL) pre-dose and 2 hours post-dose. The lower dose is
calculated to achieve blood levels within the range that were associated with reduced
hippocampal activity and improved cognition in patients with mild cognitive impairment; the
higher dose is a typical antiepileptic dose. Successful demonstration of target engagement
will be defined by an effect size of 0.5 or greater compared to placebo in reduction by
levetiracetam of hippocampal blood flow measured by ASL. The optimal dose will be defined by
maximal reduction of hippocampal perfusion in the absence of clinically-significant adverse
effects. The investigators will also study 8 healthy control subjects to verify that baseline
hippocampal blood flow is elevated in the sample of FEP subjects.


Inclusion Criteria:

1. Males and females 16 to 30 years of age, inclusive, at time of informed consent

2. 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.

3. Must have a diagnosis of either schizophrenia, schizotypal, or schizophreniform
disorder as established by a Structured Clinical Interview for DSMIV TR (SCID)

4. 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 3x the
dosing interval.

5. If female of childbearing potential, patients must

1. have a negative urine pregnancy test (all females regardless of childbearing
potential will be required to submit a pregnancy test), and

2. not be nursing or planning a pregnancy for the duration of the study through 30
days after the last dosing visit, and

3. 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:

1. Current substance abuse or positive urine toxic screen.

2. Diagnosis of major mood disorder or other Axis I disorder other than schizophrenia,
schizoaffective disorder or schizophreniform disorder.

3. Current or recent 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 investigator.

4. Pregnant or nursing or positive urine pregnancy test.

5. Significant medical or neurological illness by history or exam, including seizure
disorder, history of loss of consciousness related to head trauma or developmental
disorder including mental retardation.

6. Metal implants, pacemaker, or other metal in the body or medicinal patch.

7. History of claustrophobia.

8. Currently taking any psychotropic medication (within 4 weeks), including
antidepressant medications, benzodiazepines, antipsychotic medications, mood
stabilizers, anti-epileptic medications, and stimulants.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Donald Goff, MD
Phone: 646-754-4803
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