Pharmacological Modulation of Hippocampal Activity in Psychosis 2

NCT ID: NCT04559529

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2023-12-31

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 in people with psychotic disorders. Specifically, the investigators will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood-oxygen-level-dependent (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. 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: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Levetiracetam (LEV), then Placebo

Participants will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day.

Group Type: EXPERIMENTAL

Levetiracetam (LEV) 500 mg

Intervention Type: DRUG

The levetiracetam pill will look just like the placebo pill.

Placebo

Intervention Type: DRUG

The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.

Placebo, then Levetiracetam (LEV)

Participants will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day.

Group Type: EXPERIMENTAL

Levetiracetam (LEV) 500 mg

Intervention Type: DRUG

The levetiracetam pill will look just like the placebo pill.

Placebo

Intervention Type: DRUG

The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.

Interventions

Levetiracetam (LEV) 500 mg

The levetiracetam pill will look just like the placebo pill.

Intervention Type: DRUG

Placebo

The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.

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 Diagnostic and Statistical Manual-5 (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 (e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository; male partner sterilization; or true abstinence when this is in line with the preferred and usual lifestyle of the subject); and,

9. For females of child-bearing potential, must have a negative urine pregnancy test before MRI and drug administration.

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

1. All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.

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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 during the study.

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

10. Conditions that preclude MR scanning (as defined in the Screening Form)

11. Conditions that preclude study drug administration (as defined in the Screening Form)

All of the above and in addition:

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

2. Major psychiatric disorder as determined by Diagnostic and Statistical Manual -5 (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

Dept Chairperson Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan Heckers, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VEPP_200915

Identifier Type: -

Identifier Source: org_study_id