Pharmacological Modulation of Hippocampal Activity in Psychosis 2
Schizophrenia; Psychosis
About this trial
This is an interventional basic science trial for Schizophrenia; 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.
- 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.
- Not breastfeeding/nursing at time of screening or at any time during the study.
Inclusion criteria for healthy controls
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:
Exclusion criteria for psychosis subjects
- Age less than 18 or greater than 65.
- Not communicative in English.
- Unable to provide written informed consent.
- Current medical or neurological illness.
- History of severe head trauma.
- BMI < 17.5 or > 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)
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Levetiracetam (LEV), then Placebo
Placebo, then Levetiracetam (LEV)
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.
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.