Back to resultsPharmacologic Modulation of Hippocampal Activity in Psychosis
Primary Purpose
Schizophrenia; Psychosis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam 500 mg
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia; Psychosis focused on measuring Hippocampus
Eligibility Criteria
Inclusion criteria for psychosis subjects:
- Men and women age 18 - 65.
- Communicative in English.
- Provide voluntary, written informed consent.
- Physically healthy by medical history.
- BMI > 17.5 and < 45.
- Diagnosis of a psychotic disorder confirmed by Structured Clinical Interview for DSM-V (SCID) or diagnostic interview with a trained clinician.
- Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
- For females, no longer of child-bearing potential, or agreeing to practice effective contraception during the study; and,
- For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.
- Not breastfeeding/nursing at time of screening or at any time during the study.
Inclusion criteria for healthy controls All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.
Exclusion criteria for psychosis subjects
- Age less than 18 or greater than 65.
- Not communicative in English.
- Unable to provide written informed consent.
- Current medical or neurological illness.
- History of severe head trauma.
- BMI < 17.5 or > 45.
- Meets criteria for diagnosis of substance or alcohol use disorder within the past month.
- Positive urine pregnancy test at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study.
- Breastfeeding/nursing at time of screening or at any time during the study.
- Conditions that preclude MR scanning
- Conditions that preclude study drug administration
Exclusion criteria for healthy controls
All of the above and in addition:
- Current use of psychotropic or potentially psychoactive prescription medication.
- Major psychiatric disorder as determined by DSM-V (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Levetiracetam (LEV) 500 mg
Arm Description
Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.
Outcomes
Primary Outcome Measures
Hippocampal Activity (Arterial Spin Labeling [ASL] Study)
Change in ASL signal after drug administration
Hippocampal Recruitment (BOLD Study)
Change in BOLD signal after drug administration
Secondary Outcome Measures
Cognitive Symptoms
Change in eye-tracking relational memory task
Positive and Negative Symptoms
Change PANSS score
Full Information
NCT ID
NCT04277936
First Posted
February 18, 2020
Last Updated
July 14, 2021
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04277936
Brief Title
Pharmacologic Modulation of Hippocampal Activity in Psychosis
Official Title
Pharmacologic Modulation of Hippocampal Activity in Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Study was redesigned and submitted as a new protocol (NCT04559529).
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test whether administration of levetiracetam (LEV), a commonly used anti-epileptic that alters neurotransmitter release, can reduce hippocampal hyperactivity. Specifically, we will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood oxygen level dependence (BOLD) contrast will assess activity with a visual scene processing task that engages the anterior hippocampus and 2) arterial spin labeling (ASL) will assess baseline activity. This study will also assess whether patients have improvement in their symptoms after receiving LEV. Previous studies in people with psychotic disorders have shown that the hippocampus is hyperactive and more activity correlates with worsening of clinical symptoms. Therefore, the aim of this study is to use an intervention to further understand the underlying mechanisms of the hippocampus in psychosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia; Psychosis
Keywords
Hippocampus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levetiracetam (LEV) 500 mg
Arm Type
Experimental
Arm Description
Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam 500 mg
Other Intervention Name(s)
Keppra
Intervention Description
Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus.
Primary Outcome Measure Information:
Title
Hippocampal Activity (Arterial Spin Labeling [ASL] Study)
Description
Change in ASL signal after drug administration
Time Frame
2 hours and 2 weeks after administration
Title
Hippocampal Recruitment (BOLD Study)
Description
Change in BOLD signal after drug administration
Time Frame
2 hours and 2 weeks after administration
Secondary Outcome Measure Information:
Title
Cognitive Symptoms
Description
Change in eye-tracking relational memory task
Time Frame
2 weeks after administration
Title
Positive and Negative Symptoms
Description
Change PANSS score
Time Frame
2 weeks after administration
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 for psychosis subjects:
Men and women age 18 - 65.
Communicative in English.
Provide voluntary, written informed consent.
Physically healthy by medical history.
BMI > 17.5 and < 45.
Diagnosis of a psychotic disorder confirmed by Structured Clinical Interview for DSM-V (SCID) or diagnostic interview with a trained clinician.
Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
For females, no longer of child-bearing potential, or agreeing to practice effective contraception during the study; and,
For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.
Not breastfeeding/nursing at time of screening or at any time during the study.
Inclusion criteria for healthy controls All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.
Exclusion criteria for psychosis subjects
Age less than 18 or greater than 65.
Not communicative in English.
Unable to provide written informed consent.
Current medical or neurological illness.
History of severe head trauma.
BMI < 17.5 or > 45.
Meets criteria for diagnosis of substance or alcohol use disorder within the past month.
Positive urine pregnancy test at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study.
Breastfeeding/nursing at time of screening or at any time during the study.
Conditions that preclude MR scanning
Conditions that preclude study drug administration
Exclusion criteria for healthy controls
All of the above and in addition:
Current use of psychotropic or potentially psychoactive prescription medication.
Major psychiatric disorder as determined by DSM-V (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pharmacologic Modulation of Hippocampal Activity in Psychosis
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