Pharmacological Modulation of Hippocampal Activity in Psychosis 2
Overview
- Phase
- Phase 2
- Intervention
- Levetiracetam (LEV) 500 mg
- Conditions
- Schizophrenia; Psychosis
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Stephan Heckers
Dept Chairperson Professor
Vanderbilt University Medical Center
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for psychosis subjects
- •Men and women age 18 -
- •Communicative in English.
- •Provide voluntary, written informed consent.
- •Physically healthy by medical history.
- •BMI \> 17.5 and \<
- •Diagnosis of a psychotic disorder confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID) or diagnostic interview with a trained clinician.
- •Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
- •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,
- •For females of child-bearing potential, must have a negative urine pregnancy test before MRI and drug administration.
Exclusion Criteria
- •Exclusion criteria for psychosis subjects
- •Age less than 18 or greater than
- •Not communicative in English.
- •Unable to provide written informed consent.
- •Current medical or neurological illness.
- •History of severe head trauma.
- •BMI \< 17.5 or \>
- •Meets criteria for diagnosis of substance or alcohol use disorder within the past month.
- •Positive urine pregnancy test during the study.
- •Breastfeeding/nursing at time of screening or at any time during the study.
Arms & Interventions
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.
Intervention: Levetiracetam (LEV) 500 mg
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.
Intervention: Placebo
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.
Intervention: Levetiracetam (LEV) 500 mg
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV)
Time Frame: 2 hours after LEV administration
ASL signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo
Time Frame: 2 hours after placebo administration
ASL signal after placebo, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Placebo
Time Frame: 2 hours after placebo administration
BOLD signal after placebo, using Magnetic Resonance Imaging (MRI) scanning of the brain. This method reflects changes in oxygenation of blood in the brain during a scene-processing task that engages, or recruits, the hippocampus.
Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV)
Time Frame: 2 hours after LEV administration
BOLD signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. This method reflects changes in oxygenation of blood in the brain during a scene-processing task that engages, or recruits, the hippocampus.