Status:
TERMINATED
Pharmacologic Modulation of Hippocampal Activity in Psychosis
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Schizophrenia; Psychosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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. Specifica...
Eligibility Criteria
Inclusion
- 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 DSM-V (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; and,
- For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.
- 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
- 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 at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study.
- Breastfeeding/nursing at time of screening or at any time during the study.
- Conditions that preclude MR scanning
- Conditions that preclude study drug administration
- 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 DSM-V (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)
Exclusion
Key Trial Info
Start Date :
May 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04277936
Start Date
May 11 2020
End Date
August 31 2020
Last Update
August 5 2021
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212