Status:
COMPLETED
The Effects of Kynurenine Aminotransferase Inhibition in People With Schizophrenia
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
Kynurenic acid (KYNA) is a naturally occurring chemical in the brain. Studies with rodents indicate that levels of KYNA can impact levels of the neurotransmitters glutamate and dopamine. One way to re...
Detailed Description
The purpose of the study is to examine whether high dose N-acetylcysteine (NAC) blocks the adverse effects of increased kynurenic acid (KYNA) on selected measures of brain chemistry, function and beha...
Eligibility Criteria
Inclusion
- Males and females
- Age: 18 to 55 years
- DSM-5 Criteria for schizophrenia, schizoaffective disorder or schizophreniform disorder (documented by SCID)
- Prescription of antipsychotic medication for at least 60 days and constant dose for 30 days prior to study entry (either first or second generation antipsychotics permitted)
- Female participants must agree to use a medically accepted means of contraception
Exclusion
- DSM-5 alcohol or substance misuse disorder in the last 3 months (documented by SCID)
- History of an organic brain disorder; mental retardation; or a medical condition, whose pathology or treatment could alter cognition
- Active disorders that have been reported to affect tryptophan metabolism or interfere with absorption will be excluded (Acute Intermittent Porphyria, Celiac Disease, Crohn's Disease, Irritable Bowel Syndrome; Brune and Pflughaupt 1975; Torres et al 2007).
- Excessive self-reported daily caffeine intake, defined as intake exceeding 1000mg or the equivalent of 8 cups of coffee
- Pregnancy or lactation
- No metal in body that will interfere with MR imaging
- Monoamine oxidase inhibitors, migraine headache medications (triptans) and dextromethorphan
- Forensic or legal issues
Key Trial Info
Start Date :
January 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2024
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04013555
Start Date
January 20 2020
End Date
August 14 2024
Last Update
March 25 2025
Active Locations (1)
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1
Maryland Psychiatric Research Center (MPRC) ; the Treatment Research Program (TRP)
Catonsville, Maryland, United States, 21228