Actively Recruiting

Phase Not Applicable
Age: 16Years - 35Years
All Genders
NCT05142735

Effects of NAC on Symptoms of CHR Patients

Led by Centre for Addiction and Mental Health · Updated on 2026-03-27

90

Participants Needed

1

Research Sites

206 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effects of NAC on Symptoms of CHR Patients

Who Can Participate

Age: 16Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meeting Criteria of Psychosis-Risk Syndromes (COPS) on the Structured Interview for Psychosis-Risk Syndromes (SIPS)
  • Capacity to provide informed consent
  • If female, either not of child-bearing potential (sterilized or post-menopausal for at least 1 year) or agrees to use medically approved birth control during the study
Not Eligible

You will not qualify if you...

  • Having any other DSM-5 diagnosis at the time of the study except personality disorder, nicotine use disorder, or fully remitted substance use disorder
  • Current or past neurological conditions
  • Visual impairment not corrected by glasses or history of reading disability
  • Previous antipsychotic treatment at therapeutic dose
  • Current treatment with psychotropic medications except stable-dose antidepressants for at least 30 days
  • Pregnancy, breastfeeding, or intent to become pregnant
  • History of kidney stones
  • Current treatment with antibiotics or nitroglycerin
  • Allergy to any ingredients in the study or placebo products

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M5T 1R8

Actively Recruiting

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Research Team

M

Michael Kiang, MD, PhD

CONTACT

J

Jenny Lepock, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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