NCT01967667

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

6.8 years

First QC Date

October 17, 2013

Last Update Submit

April 27, 2021

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Glutathione levels

    Change of glutathione levels from baseline to following 3 weeks of treatment.

    Baseline and 3 weeks

Secondary Outcomes (2)

  • oxidative stress biomarker

    baseline and 3 weeks

  • inflammatory marker

    baseline and 3 weeks

Other Outcomes (2)

  • BPRS

    Baseline and 3 weeks

  • Adverse events

    Baseline and 3 weeks

Study Arms (2)

Liposomal glutathione

EXPERIMENTAL

dose steps

Dietary Supplement: Liposomal glutathione

Placebo

PLACEBO COMPARATOR

dose steps

Dietary Supplement: Placebo

Interventions

Liposomal glutathioneDIETARY_SUPPLEMENT

Escalating dose steps

Also known as: ReadiSorb glutathione
Liposomal glutathione
PlaceboDIETARY_SUPPLEMENT

escalating dose steps

Also known as: Readisorb solution without glutathione
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

glutathione pegylated liposomal doxorubicinGlutathione

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • L. Elliot Hong, MD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 23, 2013

Study Start

April 1, 2014

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)