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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.
Additional information about this dietary supplement:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal glutathione | Experimental | dose steps |
|
| Placebo | Placebo Comparator | dose steps |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal glutathione | Dietary Supplement | Escalating dose steps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glutathione levels | Change of glutathione levels from baseline to following 3 weeks of treatment. | Baseline and 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| oxidative stress biomarker | blood levels of lipid peroxidation | baseline and 3 weeks |
| inflammatory marker | Blood levels of cytokines as biomarkers of inflammation |
| Measure | Description | Time Frame |
|---|---|---|
| BPRS | Change in brief psychiatric rating scale scores from baseline to end of treatment phase and end of placebo phase. | Baseline and 3 weeks |
| Adverse events | side-effects checklist |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| L. Elliot Hong, MD | University of Maryland, College Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Psychiatric Research Center | Catonsville | Maryland | 21228 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000591311 | glutathione pegylated liposomal doxorubicin |
| D005978 | Glutathione |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Placebo | Dietary Supplement | escalating dose steps |
|
|
| baseline and 3 weeks |
| Baseline and 3 weeks |