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Levetiracetam in Early Psychosis

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ClinicalTrials.gov Identifier: NCT03129360
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psychosis Schizophrenia Schizo Affective Disorder Schizophreniform Drug: Levetiracetam Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Placebo-controlled Trial Investigating the Effects of Levetiracetam in Early Psychosis
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : February 27, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levetiracetam 185 mg
A single dose of 185mg of levetiracetam be administered orally to subjects. Subjects will undergo a 15-minute MRI scan using aterial spin labeling (ASL) before dosing and two hours post-dosing.
Drug: Levetiracetam
Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
Other Name: Keppra

Experimental: Levetiracetam 500mg
A single dose of 500mg of levetiracetam will be administered orally to subjects. Subjects will undergo a 15-minute MRI scan using aterial spin labeling (ASL) before dosing and two hours post-dosing.
Drug: Levetiracetam
Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
Other Name: Keppra

Placebo Comparator: Placebo
A single dose of placebo will be administered orally to subjects. Subjects will undergo a 15-minute MRI scan using aterial spin labeling (ASL) before dosing and two hours post-dosing.
Drug: Levetiracetam
Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
Other Name: Keppra




Primary Outcome Measures :
  1. Arterial Spin Labeling (ASL) [ Time Frame: Before and 2 hours post-treatment. ]
    Change in cerebral blood flow (CBF) as measured by ASL.



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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129360


Contacts
Contact: Michelle Worthington, MA 646 754 4803 michelle.worthington@nyumc.org
Contact: Mariel Alano, MA 646 754 5466 mariel.alano@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Michelle Worthington, MA    646-754-4803    michelle.worthington@nyumc.org   
Contact: Mariel Alano, MA    646 754 5466    mariel.alano@nyumc.org   
Principal Investigator: Donald Goff, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Donald Goff, MD NYU Langone Medical Center

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03129360     History of Changes
Other Study ID Numbers: 17-00266
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by New York University School of Medicine:
Early Psychosis
Levetiracetam

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Schizophrenia
Mood Disorders
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs