Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

NCT03034356 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: MHBB-006-16SI01CX001414
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Resting-state Neuronal Response

  4 weeks

Study Arms (2)

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).

Drug: Levetiracetam; Drug: Placebo

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).

Drug: Levetiracetam; Drug: Placebo

Interventions

Levetiracetam DRUG

Anticonvulsant drug

Also known as: Keppra

Levetiracetam, Then Placebo; Placebo, Then Levetiracetam

Placebo DRUG

Placebo

Levetiracetam, Then Placebo; Placebo, Then Levetiracetam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia or schizoaffective disorder
• Good general health
• Normal vital signs (blood pressure, pulse, respiration)

You may not qualify if:

• Substance abuse
• Significant neurological disorders
• Significant head trauma/injury
• Pregnancy
• claustrophobia
• weight\>400 lbs
• metal in the body

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jason Tregellas, PhD
• Organization: VA Eastern Colorado Health Care System

jason.tregellas@va.gov

303-724-6232

Study Officials

• Jason R. Tregellas, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: September 1, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)