Phase 2
N=62
Pharmacological Modulation of Hippocampal Activity in Psychosis 2
Schizophrenia; Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT04559529 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV) — 28.3; 27.1; 28.0; 28.5 ml/100g/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Levetiracetam (LEV) 500 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV) |
28.3; 27.1; 28.0; 28.5 | — |
| PRIMARY Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo |
28.1; 28.3; 28.1; 28.7 | — |
| PRIMARY Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV) |
-0.0342; 0.1216; 0.2915; 0.2381 | — |
| PRIMARY Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Placebo |
0.1908; 0.0507; 0.1769; 0.0703 | — |
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.
Eligibility Criteria
Inclusion Criteria
Inclusion criteria for psychosis subjects
- Men and women age 18 - 65.
- Communicative in English.
- Provide voluntary, written informed consent.
- Physically healthy by medical history.
- BMI > 17.5 and 45.
- 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.
- Conditions that preclude MR scanning (as defined in the Screening Form)
- Conditions that preclude study drug administration (as defined in the Screening Form)
Exclusion criteria for healthy controls
All of the above and in addition:
- Current use of psychotropic or potentially psychoactive prescription medication.
- Major psychiatric disorder as determined by Diagnostic and Statistical Manual -5 (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)
Data sourced from ClinicalTrials.gov (NCT04559529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.