N-acetylcysteine effects on early symptoms of schizophrenia
Effects of N-acetylcysteine on Psychosis-like Symptoms and a Neurophysiological Biomarker of the Clinical High Risk for Schizophrenia
This study is testing if a supplement called N-acetylcysteine can help people at high risk for schizophrenia feel better by reducing early symptoms over 8 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 16 Years to 35 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05142735 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of N-acetylcysteine (NAC) on individuals exhibiting clinical high-risk (CHR) symptoms for schizophrenia. It is a randomized, double-blind, placebo-controlled study involving 90 CHR patients who will receive either NAC or a placebo daily for 8 weeks. The primary focus is to assess changes in psychosis-like symptoms and neurophysiological markers, specifically the mismatch negativity (MMN) and N400 semantic priming effect, before and after the treatment period. The study aims to provide insights into NAC as a potential preventive treatment for psychosis.
Who should consider this trial
Good fit: Ideal candidates are individuals meeting the criteria for psychosis-risk syndromes who are capable of providing informed consent.
Not a fit: Patients with other DSM-5 diagnoses or those currently on psychotropic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new, less burdensome treatment option for individuals at high risk of developing schizophrenia.
How similar studies have performed: While the approach of using NAC is novel in this context, previous studies have indicated potential benefits of NAC in other psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. meeting Criteria of Psychosis-Risk Syndromes (COPS) criteria on the Structured Interview for Psychosis-Risk Syndromes (SIPS) 2. capacity to provide informed consent 3. 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 Exclusion Criteria: 1. meeting criteria for any other DSM-5 diagnosis at the time of the study (except -personality disorder, nicotine use disorder, or other substance use disorder in full remission) 2. concomitant or past neurological condition 3. visual impairment which is not corrected to normal by prescription glasses history of reading disability 4. past antipsychotic treatment at a therapeutic dose 5. current treatment with a psychotropic medication except antidepressants on which the participants has been on a stable dose for at least 30 days. 6. pregnancy (as identified on self-report and/or rapid urine pregnancy test) or intent to become pregnant according to self-report 7. breastfeeding or plan to do so 8. history of kidney stones 9. current treatment with an antibiotic 10. current treatment with nitroglycerin 11. allergy to any ingredients in either the investigational product or placebo product
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Michael Kiang, MD, PhD — Centre for Addiction and Mental Health
- Study coordinator: Michael Kiang, MD, PhD
- Email: michael.kiang@camh.ca
- Phone: 416-535-8501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.