Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
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ClinicalTrials.gov Identifier: NCT03034356 |
Recruitment Status :
Recruiting
First Posted : January 27, 2017
Last Update Posted : October 7, 2022
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Condition or disease | Intervention/treatment | Phase |
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Schizophrenia | Drug: Levetiracetam Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia |
Actual Study Start Date : | September 1, 2018 |
Estimated Primary Completion Date : | September 30, 2023 |
Estimated Study Completion Date : | September 30, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: 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).
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Drug: Levetiracetam
Anticonvulsant drug
Other Name: Keppra Drug: Placebo Placebo |
Experimental: 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).
|
Drug: Levetiracetam
Anticonvulsant drug
Other Name: Keppra Drug: Placebo Placebo |
- Neurocognitive function [ Time Frame: 4 weeks ]Cognitive function as measured by the Repeatable Battery for the Assessment of Neurological Status (RBANS)
- Resting-state neuronal response [ Time Frame: 4 weeks ]Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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MRI-specific exclusion criteria, e.g.,:
- claustrophobia
- weight>400 lbs
- metal in the body

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034356
Contact: Jason R Tregellas, PhD | (303) 315-1086 | Jason.Tregellas@va.gov |
United States, Colorado | |
Rocky Mountain Regional VA Medical Center, Aurora, CO | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Jason R Tregellas, PhD 303-315-1086 Jason.Tregellas@va.gov | |
Principal Investigator: Jason R. Tregellas, PhD |
Principal Investigator: | Jason R. Tregellas, PhD | Rocky Mountain Regional VA Medical Center, Aurora, CO |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT03034356 |
Other Study ID Numbers: |
MHBB-006-16S I01CX001414 ( U.S. NIH Grant/Contract ) |
First Posted: | January 27, 2017 Key Record Dates |
Last Update Posted: | October 7, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | A de-identified, anonymized dataset will be created and shared. |
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 |
Schizophrenia |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |
Levetiracetam Anticonvulsants Nootropic Agents |