Trial · NCT03034356

Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

NCT03034356, Phase 1, Phase 2, Completed, VA Office of Research and Development; results first posted 2025-07-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia. Trials, record NCT03034356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03034356

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
NCT number: NCT03034356
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 67 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Schizophrenia
Interventions: Levetiracetam, Placebo
First posted: 2017-01-27
Last updated: 2026-08-11
Results first posted: 2025-07-14

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Neurocognitive Function	Baseline and change from baseline to 4 weeks for each intervention	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).
Secondary	Resting-state Neuronal Response	Baseline and change from baseline to 4 weeks for each intervention	Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest (fractional amplitude of low frequency fluctuations, fALFF).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Neurocognitive Function	4 weeks	All participants who received at least one dose of each intervention and completed all study visits were included.	Total score	MEAN
SECONDARY	Resting-state Neuronal Response	4 weeks

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Neurocognitive Function	Levetiracetam	RBANS at Baseline	73.68	Standard Deviation 14.69	Total score
Neurocognitive Function	Placebo	RBANS at Baseline	74.04	Standard Deviation 12.02	Total score
Neurocognitive Function	Levetiracetam	Change from Baseline at 4 weeks	3.36	Standard Deviation 7.29	Total score
Neurocognitive Function	Placebo	Change from Baseline at 4 weeks	3.96	Standard Deviation 6.33	Total score

Source ClinicalTrials.gov

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Baseline	STARTED	Levetiracetam, Then Placebo	20
Baseline	STARTED	Placebo, Then Levetiracetam	21
Baseline	COMPLETED	Levetiracetam, Then Placebo	16
Baseline	COMPLETED	Placebo, Then Levetiracetam	16
Baseline	NOT COMPLETED	Levetiracetam, Then Placebo	4
Baseline	NOT COMPLETED	Placebo, Then Levetiracetam	5
Post-Intervention 1 (4 Weeks)	STARTED	Levetiracetam, Then Placebo	16
Post-Intervention 1 (4 Weeks)	STARTED	Placebo, Then Levetiracetam	16
Post-Intervention 1 (4 Weeks)	COMPLETED	Levetiracetam, Then Placebo	13
Post-Intervention 1 (4 Weeks)	COMPLETED	Placebo, Then Levetiracetam	14

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Levetiracetam	1	30
other	Abdominal pain	Gastrointestinal disorders	Placebo	3	27
other	Hallucinations	Psychiatric disorders	Levetiracetam	1	30
other	Hallucinations	Psychiatric disorders	Placebo	3	27
other	Headache	Nervous system disorders	Levetiracetam	3	30
other	Headache	Nervous system disorders	Placebo	2	27
other	Irritability	Psychiatric disorders	Levetiracetam	3	30
other	Irritability	Psychiatric disorders	Placebo	0	27
other	Paranoia	Psychiatric disorders	Levetiracetam	1	30
other	Paranoia	Psychiatric disorders	Placebo	3	27

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Levetiracetam	0	30
Total, all-cause mortality	Placebo	0	27
Total, other adverse events	Levetiracetam	16	30
Total, other adverse events	Placebo	16	27
Total, serious adverse events	Levetiracetam	0	30
Total, serious adverse events	Placebo	0	27

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
I01CX001414	Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia	TREGELLAS, JASON R	VA EASTERN COLORADO HEALTH CARE SYSTEM	Veterans Affairs	2018 to 2023

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Levetiracetam vs Placebo: deaths from any cause	Trial comparisons
Levetiracetam vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03034356

GET https://conductscience.org/api/trials/v1/NCT03034356/flow?page=2

API reference For AI assistants