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| ID | Type | Description | Link |
|---|---|---|---|
| I01CX001414 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam, Then Placebo | Experimental | 4 weeks of levetiracetam administration (125 mg pill, bid), followed by a 4-week washout, then 4 weeks of placebo pill administration (bid). |
|
| Placebo, Then Levetiracetam | Experimental | 4 weeks of placebo administration (bid), followed by a 4-week washout, then 4 weeks of levetiracetam administration (125 mg pill, bid). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Anticonvulsant drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive Function | Cognitive function as measured by the Repeatable Battery for the Assessment of Neurological Status (RBANS; total score). Scores are scaled with a mean of 100 and standard deviation of 15 (higher scores indicating better outcome). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-state Neuronal Response | Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Substance abuse
Significant neurological disorders
Significant head trauma/injury
Pregnancy
MRI-specific exclusion criteria, e.g.,:
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| Name | Affiliation | Role |
|---|---|---|
| Jason R. Tregellas, PhD | Rocky Mountain Regional VA Medical Center, Aurora, CO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045-7211 | United States |
A de-identified, anonymized dataset will be created and shared.
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41 out of 67 participants were randomized. Of those not randomized, 23 did not meet inclusion criteria and 3 declined to participate.
67 patients were screened for eligibility between October 2018 and September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam, Then Placebo | 4 weeks of levetiracetam administration (125 mg pill, bid), followed by a 4-week washout, then 4 weeks of placebo pill administration (bid). Levetiracetam: Anticonvulsant drug Placebo: Placebo |
| FG001 | Placebo, Then Levetiracetam | 4 weeks of placebo administration (bid), followed by a 4-week washout, then 4 weeks of levetiracetam administration (125 mg pill, bid). Levetiracetam: Anticonvulsant drug Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
|
| |||||||||||||||||||||
| Post-Intervention 1 (4 Weeks) |
| ||||||||||||||||||||||
| Post-Washout (4 Weeks) |
| ||||||||||||||||||||||
| Post-Intervention 2 (4 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam, Then Placebo | 4 weeks of levetiracetam administration (125 mg pill, bid), followed by a 4-week washout, then 4 weeks of placebo pill administration (bid). Levetiracetam: Anticonvulsant drug Placebo: Placebo |
| BG001 | Placebo, Then 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 | Neurocognitive Function | Cognitive function as measured by the Repeatable Battery for the Assessment of Neurological Status (RBANS; total score). Scores are scaled with a mean of 100 and standard deviation of 15 (higher scores indicating better outcome). | All participants who received at least one dose of each intervention and completed all study visits were included. | Posted | Mean | Standard Deviation | Total score | 4 weeks |
|
4 weeks for each intervention
All participants who received at least one dose of intervention.
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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 | Levetiracetam | Participants who received levetiracetam administration (125 mg pill, bid) for either the first or last 4 weeks of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Tregellas, PhD | VA Eastern Colorado Health Care System | 303-724-6232 | jason.tregellas@va.gov |
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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 | Jun 12, 2023 | Jun 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Placebo | Drug | Placebo |
|
| Physician Decision |
|
| NOT COMPLETED |
|
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| NOT COMPLETED |
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| NOT COMPLETED |
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4 weeks of placebo administration (bid), followed by a 4-week washout, then 4 weeks of levetiracetam administration (125 mg pill, bid). Levetiracetam: Anticonvulsant drug Placebo: Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Resting-state Neuronal Response | Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest. | Not Posted | 4 weeks | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 16 |
| 30 |
| EG001 | Placebo | Participants who received placebo administration (125 mg pill, bid) for either the first or last 4 weeks of the study. | 0 | 27 | 0 | 27 | 16 | 27 |
| Hallucinations | Psychiatric disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Paranoia | Psychiatric disorders | Systematic Assessment |
|
| Sedation or Drowsiness | General disorders | Systematic Assessment |
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| Visual Disturbance | Eye disorders | Systematic Assessment |
|
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |