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Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

Primary Purpose

Schizophrenia

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam
Placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Good general health
  • Normal vital signs (blood pressure, pulse, respiration)

Exclusion Criteria:

  • Substance abuse
  • Significant neurological disorders
  • Significant head trauma/injury
  • Pregnancy

  • MRI-specific exclusion criteria, e.g.,:

    • claustrophobia
    • weight>400 lbs
    • metal in the body

Sites / Locations

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Levetiracetam, Then Placebo

Placebo, Then Levetiracetam

Arm Description

4 weeks of levetiracetam administration (125 mg pill, bid), followed by a 4-week washout, then 4 weeks of placebo pill administration (bid).

4 weeks of placebo administration (bid), followed by a 4-week washout, then 4 weeks of levetiracetam administration (125 mg pill, bid).

Outcomes

Primary Outcome Measures

Neurocognitive function
Cognitive function as measured by the Repeatable Battery for the Assessment of Neurological Status (RBANS)

Secondary Outcome Measures

Resting-state neuronal response
Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest.

Full Information

First Posted
January 25, 2017
Last Updated
October 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03034356
Brief Title
Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
Official Title
Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study plans to learn more about the effects of levetiracetam (LEV) on brain activity and cognition in schizophrenia and schizoaffective disorder. Levetiracetam is an anti-seizure drug, also called an anticonvulsant.
Detailed Description
Cognitive symptoms are not currently well-managed in Veterans with schizophrenia, leading to substantially diminished quality of life. Improved treatment strategies clearly are needed. Recent studies suggest taht an overactive hippocampus is associated with cognitive deficits in the illness. Based on findings that the anti-epileptic drug levetiracetam (LEV) reduces hippocampal activity and improves cognition in other clinical populations while being safe and well-tolerated, this study will examine the effects of the drug on hippocampal activity and cognition in Veterans with schizophrenia. In this crossover design, participants will take LEV for 4 weeks and placebo pills for 4 weeks, but will not know the order in which they are taking them.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam, Then Placebo
Arm Type
Experimental
Arm Description
4 weeks of levetiracetam administration (125 mg pill, bid), followed by a 4-week washout, then 4 weeks of placebo pill administration (bid).
Arm Title
Placebo, Then Levetiracetam
Arm Type
Experimental
Arm Description
4 weeks of placebo administration (bid), followed by a 4-week washout, then 4 weeks of levetiracetam administration (125 mg pill, bid).
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
Anticonvulsant drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Neurocognitive function
Description
Cognitive function as measured by the Repeatable Battery for the Assessment of Neurological Status (RBANS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Resting-state neuronal response
Description
Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder Good general health Normal vital signs (blood pressure, pulse, respiration) Exclusion Criteria: Substance abuse Significant neurological disorders Significant head trauma/injury Pregnancy MRI-specific exclusion criteria, e.g.,: claustrophobia weight>400 lbs metal in the body
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason R. Tregellas, PhD
Organizational Affiliation
Rocky Mountain Regional VA Medical Center, Aurora, CO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified, anonymized dataset will be created and shared.

Learn more about this trial

Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

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