Effects of N-acetylcysteine on Psychosis-like Symptoms and a Neurophysiological Biomarker of the Clinical High Risk for Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Schizophrenia is a chronic debilitating psychotic disorder. Identifying persons with clinical high-risk (CHR) symptoms, which are like those of schizophrenia but less severe, and providing psychiatric care to these individuals has been shown to help prevent psychosis. Current medications used for CHR symptoms, however, are associated with substantial side effect burden. Therefore, practice guidelines do not recommend current medications as routine treatment for the CHR state, and there is a need to identify new treatments for this condition. Research suggests that abnormal brain oxidative stress may contribute to schizophrenia, offering a potential novel treatment target in the CHR state. Oxidative stress is an excess of free radicals, which are generated from normal metabolism and environmental exposures, and can damage cells. Antioxidants in the body normally neutralize free radicals. Antioxidant deficiency could result in excess oxidative stress that damages brain cells, leading to schizophrenia. Recent studies suggest that N-acetylcysteine (NAC), a precursor of the most abundant brain antioxidant, glutathione, may be a safe, well-tolerated treatment for schizophrenia. In light of this, NAC may also reduce symptoms and brain abnormalities in CHR patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 35
Healthy Volunteers: f
View:

• meeting Criteria of Psychosis-Risk Syndromes (COPS) criteria on the Structured Interview for Psychosis-Risk Syndromes (SIPS)

• capacity to provide informed consent

• if female, participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure or have been post-menopausal for at least 1 year prior to screening OR participant is of child-bearing potential and agrees to use a medically approved method of birth control for the duration of the study

Locations
Other Locations
Canada
Centre for Addiction and Mental Health
RECRUITING
Toronto
Contact Information
Primary
Michael Kiang, MD, PhD
michael.kiang@camh.ca
416-535-8501
Backup
Jenny Lepock, PhD
jenny.lepock@camh.ca
416-535-8501
Time Frame
Start Date: 2023-01-13
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 90
Treatments
Experimental: Experimental
N-Acetylcysteine 2000 mg (4 x 500-mg tablets) orally every morning for 8 weeks
Placebo_comparator: Placebo Comparator
N-Acetylcysteine Placebo tablet matching N-Acetylcysteine orally every morning for 8 weeks
Related Therapeutic Areas
Sponsors
Leads: Centre for Addiction and Mental Health

This content was sourced from clinicaltrials.gov