Back to results

Levetiracetam in Early Psychosis

Primary Purpose

Psychosis, Schizophrenia, Schizo Affective Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Levetiracetam

Placebo

About this trial

This is an interventional other trial for Psychosis focused on measuring Early Psychosis, Levetiracetam

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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:
1. Have a negative urine pregnancy test (all females regardless of childbearing potential will be required to submit a pregnancy test)
2. Not be nursing or planning a pregnancy for the duration of the study through 30 days after the last dosing visit
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:

Current substance abuse or dependence for substances other than nicotine and THC (i.e., alcohol, amphetamines, barbiturates)
1. A positive urine toxic screen (excluding THC, tricyclic antidepressants, or benzodiazepines (if prescribed))
2. Moderate or severe cannabis use disorder
3. Use of marijuana within the 72 hours prior to MRI scanning by self report
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)

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Levetiracetam 185 mg

Levetiracetam 500mg

Placebo

Arm Description

A single dose of 185mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.

A single dose of 500mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.

A single dose of placebo administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.

Outcomes

Primary Outcome Measures

Change in Cerebral Blood Flow (CBF)

CBF will be measured by Arterial Spin Labeling (ASL)

Secondary Outcome Measures

Full Information

NCT ID

NCT03129360

First Posted

April 17, 2017

Last Updated

October 26, 2022

Sponsor

NYU Langone Health

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT03129360

Brief Title

Levetiracetam in Early Psychosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

August 18, 2017 (Actual)

Primary Completion Date

November 3, 2021 (Actual)

Study Completion Date

November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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 EP subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychosis, Schizophrenia, Schizo Affective Disorder, Schizophreniform

Keywords

Early Psychosis, Levetiracetam

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levetiracetam 185 mg

Arm Type

Experimental

Arm Description

A single dose of 185mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.

Arm Title

Levetiracetam 500mg

Arm Type

Experimental

Arm Description

A single dose of 500mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

A single dose of placebo administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.

Intervention Type

Drug

Intervention Name(s)

Levetiracetam

Other Intervention Name(s)

Keppra

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Prepared in capsules to appear identical to levetiracetam.

Primary Outcome Measure Information:

Title

Change in Cerebral Blood Flow (CBF)

Description

CBF will be measured by Arterial Spin Labeling (ASL)

Time Frame

Baseline, 2 Hours Post-Treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Use of marijuana within the 72 hours prior to MRI scanning by self report 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald Goff, MD

Organizational Affiliation

NYU Langone Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: donald.goff@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to donald.goff@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Levetiracetam in Early Psychosis

We'll reach out to this number within 24 hrs