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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 in people with psychotic disorders. Specifically, the investigators will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood-oxygen-level-dependent (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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam (LEV), then Placebo | Experimental | Participants will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day. |
|
| Placebo, then Levetiracetam (LEV) | Experimental | Participants will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam (LEV) 500 mg | Drug | The levetiracetam pill will look just like the placebo pill. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV) | ASL signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity. | 2 hours after LEV administration |
| Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo | ASL signal after placebo, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity. | 2 hours after placebo administration |
| Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV) | BOLD signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. This method reflects changes in oxygenation of blood in the brain during a scene-processing task that engages, or recruits, the hippocampus. | 2 hours after LEV administration |
| Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Placebo | BOLD signal after placebo, using Magnetic Resonance Imaging (MRI) scanning of the brain. This method reflects changes in oxygenation of blood in the brain during a scene-processing task that engages, or recruits, the hippocampus. | 2 hours after placebo administration |
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Inclusion Criteria:
Inclusion criteria for psychosis subjects
Inclusion criteria for healthy controls
1. All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.
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Exclusion Criteria:
Exclusion criteria for psychosis subjects
Exclusion criteria for healthy controls
All of the above and in addition:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Heckers, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Control Participants: Levetiracetam (LEV), Then Placebo | Healthy control participants will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day. |
| FG001 | Healthy Control Participants: Placebo, Then Levetiracetam (LEV) | Healthy control participants will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day. |
| FG002 | Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo | Participants with schizophrenia will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day. |
| FG003 | Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV) | Participants with schizophrenia will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
|
| ||||||||||||||||||
| Washout (At Least 7 Days) |
| |||||||||||||||||||
| Second Intervention (1 Day) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Control Participants: Levetiracetam (LEV), Then Placebo | Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV) | ASL signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity. | The overall number of participants analyzed is inconsistent with the numbers provided in the participant flow module due to MRI scanner or participant error during the collection of the ASL sequence. However, these participants still included useful imaging data collected in other imaging sequences during the study. | Posted | Mean | 95% Confidence Interval | ml/100g/min | 2 hours after LEV administration |
|
Up to 4 hours after levetiracetam or placebo administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Control Participants: Levetiracetam (LEV) | All healthy control participants that received LEV. All individuals contributed data to the study outcomes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan Heckers, MD; Principal Investigator | Vanderbilt University Medical Center | 6153222665 | stephan.heckers@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2021 | Nov 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| D007978 | Levamisole |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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2-way crossover, double-blind, randomized controlled study
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During Visit 2, participants will be randomly assigned to an intervention arm in which they will receive two 250mg LEV capsules or two placebo capsules. Both the participant and the research team will be blinded to which arm each participant is in. During Visit 3, the participant will undergo cross-over and receive either two 250mg LEV capsules or two placebo capsules (whichever intervention they did not receive in Visit 2).
|
| Placebo | Drug | The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. |
|
| Withdrawn due to inability to complete imaging |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Healthy Control Participants: Placebo, Then Levetiracetam (LEV) | Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. |
| BG002 | Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo | Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. |
| BG003 | Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV) | Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Healthy Control Participants: Placebo, Then Levetiracetam (LEV) | Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. |
| OG002 | Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo | Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. |
| OG003 | Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV) | Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. |
|
|
| Primary | Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo | ASL signal after placebo, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity. | The overall number of participants analyzed is inconsistent with the numbers provided in the participant flow module due to MRI scanner or participant error during the collection of the ASL sequence. However, these participants still included useful imaging data collected in other imaging sequences during the study. | Posted | Mean | 95% Confidence Interval | ml/100g/min | 2 hours after placebo administration |
|
|
|
| Primary | Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV) | BOLD signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. This method reflects changes in oxygenation of blood in the brain during a scene-processing task that engages, or recruits, the hippocampus. | The overall number of participants analyzed is inconsistent with the numbers provided in the participant flow module due to MRI scanner or participant error during the collection of the recruitment data using the BOLD signal. However, these participants still included useful imaging data collected in other imaging sequences during the study. | Posted | Mean | 95% Confidence Interval | BOLD percent signal change | 2 hours after LEV administration |
|
|
|
| Primary | Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Placebo | BOLD signal after placebo, using Magnetic Resonance Imaging (MRI) scanning of the brain. This method reflects changes in oxygenation of blood in the brain during a scene-processing task that engages, or recruits, the hippocampus. | The overall number of participants analyzed is inconsistent with the numbers provided in the participant flow module due to MRI scanner or participant error during the collection of the recruitment data using the BOLD signal. However, these participants still included useful imaging data collected in other imaging sequences during the study. | Posted | Mean | 95% Confidence Interval | BOLD percent signal change | 2 hours after placebo administration |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Healthy Control Participants: Placebo | All healthy control participants that received placebo. All individuals contributed data to the study outcomes. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Patients With Schizophrenia: Levetiracetam (LEV) | All patients with schizophrenia that received LEV, including individuals that did not contribute data to the study outcomes. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG003 | Patients With Schizophrenia: Placebo | All patients with schizophrenia that received placebo, including individuals that did not contribute data to the study outcomes. | 0 | 30 | 0 | 30 | 1 | 30 |
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |