Pharmacologic Modulation of Hippocampal Activity in Psychosis

NCT ID: NCT04277936

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2020-08-31

Brief Summary

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. Specifically, we will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood oxygen level dependence (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. This study will also assess whether patients have improvement in their symptoms after receiving LEV. 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.

Conditions

Schizophrenia; Psychosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Levetiracetam (LEV) 500 mg

Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.

Group Type: EXPERIMENTAL

Levetiracetam 500 mg

Intervention Type: DRUG

Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus.

Interventions

Levetiracetam 500 mg

Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus.

Intervention Type: DRUG

Other Intervention Names

Keppra

Eligibility Criteria

Inclusion Criteria

1. Men and women age 18 - 65.

2. Communicative in English.

3. Provide voluntary, written informed consent.

4. Physically healthy by medical history.

5. BMI > 17.5 and < 45.

6. Diagnosis of a psychotic disorder confirmed by Structured Clinical Interview for DSM-V (SCID) or diagnostic interview with a trained clinician.

7. Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.

8. For females, no longer of child-bearing potential, or agreeing to practice effective contraception during the study; and,

9. For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.

10. Not breastfeeding/nursing at time of screening or at any time during the study.

Exclusion Criteria

1. Age less than 18 or greater than 65.

2. Not communicative in English.

3. Unable to provide written informed consent.

4. Current medical or neurological illness.

5. History of severe head trauma.

6. BMI < 17.5 or > 45.

7. Meets criteria for diagnosis of substance or alcohol use disorder within the past month.

8. Positive urine pregnancy test at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study.

9. Breastfeeding/nursing at time of screening or at any time during the study.

10. Conditions that preclude MR scanning

11. Conditions that preclude study drug administration

All of the above and in addition:

1. Current use of psychotropic or potentially psychoactive prescription medication.

2. Major psychiatric disorder as determined by DSM-V (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Stephan Heckers

Department Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

VEPP_200218

Identifier Type: -

Identifier Source: org_study_id