Biological Evaluation of Dietary Supplement Liposomal Glutathione

Completed · Not applicable · Has a placebo group

Conditions studied: Schizophrenia

In brief

Low levels of antioxidant molecules such as glutathione have been found in people with a diagnosis of schizophrenia. However, oral glutathione is not well absorbed because the compound is mostly broken down in the gastrointestinal system. Liposomes are tiny droplets of oil particles that encapsulate and protect the glutathione. In this study we will evaluate a liposomal formulation of glutathione for tolerability and to examine if this formulation serves the function of increasing glutathione in the brain and body.

Key facts

Study ID

NCT01967667

Run by

University of Maryland, Baltimore

People needed

11

Starts

2014-04-01

Expected to finish

2021-02-01

Last updated by the study team

2021-04-28

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age range: 18-60
• DSM diagnosis of schizophrenia spectrum disorder, including schizophrenia, schizoaffective disorder, and schizophreniform disorder
• Ability to give written informed consent (Evaluation to Sign Consent score 10 or greater)
• Clinically stable with no change in antipsychotic medications nor significant increase of daily dose for 2 weeks prior to enrollment
• Low baseline blood glutathione level (GSH < 890 umol/l)

You may not qualify if…

• History of major medical illness including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)
• History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration
• DSM diagnosis of substance dependence within 6 months except nicotine and marijuana, or substance abuse in past month
• Uncontrolled blood pressure (persistent systolic above 165 or diastolic above 100)
• On medication containing cholesterol absorption inhibitor such as ezetimibe (Brand names Zetia, Ezetrol, Vytorin, and Inegy)
• Women who have positive urine pregnancy tests
• Women who plan to become pregnant, or are breastfeeding
• Unable to undergo MRI scanning due to metallic devices or objects or claustrophobia
• Already taking dietary antioxidant supplements such as n-acetylcysteine or fish oil on regular basis (more than twice a week) in the last 3 months
• History of allergy to soy or soy products
• Hyperlipidemia (baseline LDL > 1.5 x upper limit of normal)
• Liver impairment (baseline AST or ALT > 2.0 x upper limit of normal)

Where it is running

• Maryland Psychiatric Research Center — Catonsville, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.