Pharmacologic Modulation of Hippocampal Activity in Psychosis

Schizophrenia; Psychosis Clinical Trial

Official title:

Pharmacologic Modulation of Hippocampal Activity in Psychosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04277936
• Other study ID #: VEPP_200218
• Status: Terminated
• Phase: Phase 2
• Start date: May 11, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: July 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria for psychosis subjects:

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.

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

Exclusion criteria for psychosis subjects

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

Exclusion criteria for healthy controls

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)

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia; Psychosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hippocampal Activity (Arterial Spin Labeling [ASL] Study)	Change in ASL signal after drug administration	2 hours and 2 weeks after administration
Primary	Hippocampal Recruitment (BOLD Study)	Change in BOLD signal after drug administration	2 hours and 2 weeks after administration
Secondary	Cognitive Symptoms	Change in eye-tracking relational memory task	2 weeks after administration
Secondary	Positive and Negative Symptoms	Change PANSS score	2 weeks after administration