Prodromal SchizophreniaNCT05142735
Effects of NAC on Symptoms of CHR Patients
A study testing N-Acetylcysteine in people with Prodromal Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Prodromal Schizophrenia
- What is being tested?
- N-Acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
- concomitant or past neurological condition
- visual impairment which is not corrected to normal by prescription glasses history of reading disability
- past antipsychotic treatment at a therapeutic dose
- current treatment with a psychotropic medication except antidepressants on which the participants has been on a stable dose for at least 30 days.
- pregnancy (as identified on self-report and/or rapid urine pregnancy test) or intent to become pregnant according to self-report
Show all 11Show fewer
- breastfeeding or plan to do so
- history of kidney stones
- current treatment with an antibiotic
- current treatment with nitroglycerin
- allergy to any ingredients in either the investigational product or placebo product
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
Jenny Lepock, PhD, 4167026423, jenny.lepock@camh.ca
Michael Kiang, michael.kiang@camh.ca
About this study
Official title: Effects of N-acetylcysteine on Psychosis-like Symptoms and a Neurophysiological Biomarker of the Clinical High Risk for Schizophrenia
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.
Read the detailed description
The primary aim is to examine the effect of NAC on psychosis-like symptoms in CHR patients. Secondary aims are to examine the effect of NAC, in these patients, on the amplitude of the mismatch negativity (MMN), an electroencephalographic event-related potential (ERP) response to rare sounds among frequent ones; and the amplitude of the N400 semantic priming effect, an ERP response to unexpected compared to expected meaningful stimuli (e.g., words, pictures); both of which have been found to be reduced in both schizophrenia and the CHR state.
This will be a randomized, double-blind, placebo-controlled trial. Ninety CHR patients will take either NAC 2000 mg orally or placebo, daily for 8 weeks. Psychosis-like symptoms will be assessed at baseline, week 4 and week 8 using the Positive symptom score of the Scale of Psychosis-Risk Symptoms in the Structured Interview for Psychosis-Risk Syndromes. MMN amplitude and the N400 semantic priming effect will be measured at baseline and week 8. We hypothesize that patients will have more improvement in psychosis-like symptoms, and greater increases in MMN amplitudes and N400 semantic priming effects, after taking NAC vs. placebo. If we find that NAC improves psychosis-like symptoms and/or these neurophysiological biomarkers of the CHR state, this would support further research on NAC as a preventive treatment against psychosis.
- Conditions
- Prodromal Schizophrenia
- Being tested
- N-Acetylcysteine, Placebo
- Keywords
- psychosis, schizophrenia, N-acetylcysteine, prodrome, mismatch negativity, event-related potentials, clinical high risk state
- Medical subject headings
- Schizotypal Personality Disorder, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-AcetylcysteineDietary supplement
Also called NAC
2000 mg (4 x 500-mg tablets) every morning
PlaceboDietary supplement
4 placebo tablets every morning
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | N-Acetylcysteine 2000 mg (4 x 500-mg tablets) orally every morning for 8 weeks Receives: Dietary Supplement: N-Acetylcysteine |
| Placebo Comparator | Placebo comparator | N-Acetylcysteine Placebo tablet matching N-Acetylcysteine orally every morning for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in positive psychosis-like symptoms from baseline to 8 weeks
Measured by the Positive symptom score of the Scale of Psychosis-Risk Symptoms, where the minimum score is 0 and the maximum score is 30, and higher scores mean a worse outcome.
Measured: Week 0 to week 8
Secondary outcomes (2)
Change in mismatch negativity (MMN) amplitude from baseline to 8 weeks
MMN amplitude will be measured as mean voltage from 135-205 ms post-stimulus onset of the ERP waveform formed by subtracting the average for standard tones from the average for deviant tones.
Measured: Week 0 to week 8
Change in N400 semantic priming effect from baseline to 8 weeks
N400 semantic priming effect will be measured as mean voltage from 300-500 ms post-stimulus onset of the ERP waveform formed by subtracting the average for related stimuli from the average for unrelated stimuli.
Measured: Week 0 to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start13 Jan 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Prodromal SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of NAC or placebo groups in parallel for the duration of the study. This will be a randomized, double-blind, placebo-controlled trial. Participants will be randomized to take either NAC 2000 mg or placebo, in the form of oral capsules, every morning for 8 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kiang, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142735
- Sponsor's protocol ID
- 054-2020
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Addington J, Addington D, Abidi S, Raedler T, Remington G. Canadian Treatment Guidelines for Individuals at Clinical High Risk of Psychosis. Can J Psychiatry. 2017 Sep;62(9):656-661. doi: 10.1177/0706743717719895. Epub 2017 Jul 21.
PubMed 28730848Atkinson RJ, Michie PT, Schall U. Duration mismatch negativity and P3a in first-episode psychosis and individuals at ultra-high risk of psychosis. Biol Psychiatry. 2012 Jan 15;71(2):98-104. doi: 10.1016/j.biopsych.2011.08.023. Epub 2011 Oct 13.
PubMed 22000060Breier A, Liffick E, Hummer TA, Vohs JL, Yang Z, Mehdiyoun NF, Visco AC, Metzler E, Zhang Y, Francis MM. Effects of 12-month, double-blind N-acetyl cysteine on symptoms, cognition and brain morphology in early phase schizophrenia spectrum disorders. Schizophr Res. 2018 Sep;199:395-402. doi: 10.1016/j.schres.2018.03.012. Epub 2018 Mar 24.
PubMed 29588126Cabungcal JH, Counotte DS, Lewis E, Tejeda HA, Piantadosi P, Pollock C, Calhoon GG, Sullivan E, Presgraves E, Kil J, Hong LE, Cuenod M, Do KQ, O'Donnell P. Juvenile antioxidant treatment prevents adult deficits in a developmental model of schizophrenia. Neuron. 2014 Sep 3;83(5):1073-1084. doi: 10.1016/j.neuron.2014.07.028. Epub 2014 Aug 14.
PubMed 25132466Conus P, Seidman LJ, Fournier M, Xin L, Cleusix M, Baumann PS, Ferrari C, Cousins A, Alameda L, Gholam-Rezaee M, Golay P, Jenni R, Woo TW, Keshavan MS, Eap CB, Wojcik J, Cuenod M, Buclin T, Gruetter R, Do KQ. N-acetylcysteine in a Double-Blind Randomized Placebo-Controlled Trial: Toward Biomarker-Guided Treatment in Early Psychosis. Schizophr Bull. 2018 Feb 15;44(2):317-327. doi: 10.1093/schbul/sbx093.
PubMed 29462456Flatow J, Buckley P, Miller BJ. Meta-analysis of oxidative stress in schizophrenia. Biol Psychiatry. 2013 Sep 15;74(6):400-9. doi: 10.1016/j.biopsych.2013.03.018. Epub 2013 May 15.
PubMed 23683390Hsieh MH, Shan JC, Huang WL, Cheng WC, Chiu MJ, Jaw FS, Hwu HG, Liu CC. Auditory event-related potential of subjects with suspected pre-psychotic state and first-episode psychosis. Schizophr Res. 2012 Sep;140(1-3):243-9. doi: 10.1016/j.schres.2012.06.021. Epub 2012 Jul 10.
PubMed 22784684Jahshan C, Cadenhead KS, Rissling AJ, Kirihara K, Braff DL, Light GA. Automatic sensory information processing abnormalities across the illness course of schizophrenia. Psychol Med. 2012 Jan;42(1):85-97. doi: 10.1017/S0033291711001061. Epub 2011 Jul 11.
PubMed 21740622Kim M, Lee TH, Yoon YB, Lee TY, Kwon JS. Predicting Remission in Subjects at Clinical High Risk for Psychosis Using Mismatch Negativity. Schizophr Bull. 2018 Apr 6;44(3):575-583. doi: 10.1093/schbul/sbx102.
PubMed 29036493Lavoie S, Jack BN, Griffiths O, Ando A, Amminger P, Couroupis A, Jago A, Markulev C, McGorry PD, Nelson B, Polari A, Yuen HP, Whitford TJ. Impaired mismatch negativity to frequency deviants in individuals at ultra-high risk for psychosis, and preliminary evidence for further impairment with transition to psychosis. Schizophr Res. 2018 Jan;191:95-100. doi: 10.1016/j.schres.2017.11.005. Epub 2017 Nov 11.
PubMed 29132815Lepock JR, Ahmed S, Mizrahi R, Gerritsen CJ, Maheandiran M, Drvaric L, Bagby RM, Korostil M, Light GA, Kiang M. Relationships between cognitive event-related brain potential measures in patients at clinical high risk for psychosis. Schizophr Res. 2020 Dec;226:84-94. doi: 10.1016/j.schres.2019.01.014. Epub 2019 Jan 22.
PubMed 30683525Miller TJ, McGlashan TH, Rosen JL, Cadenhead K, Cannon T, Ventura J, McFarlane W, Perkins DO, Pearlson GD, Woods SW. Prodromal assessment with the structured interview for prodromal syndromes and the scale of prodromal symptoms: predictive validity, interrater reliability, and training to reliability. Schizophr Bull. 2003;29(4):703-15. doi: 10.1093/oxfordjournals.schbul.a007040.
PubMed 14989408Nagai T, Tada M, Kirihara K, Yahata N, Hashimoto R, Araki T, Kasai K. Auditory mismatch negativity and P3a in response to duration and frequency changes in the early stages of psychosis. Schizophr Res. 2013 Nov;150(2-3):547-54. doi: 10.1016/j.schres.2013.08.005. Epub 2013 Sep 6.
PubMed 24012461Perez VB, Woods SW, Roach BJ, Ford JM, McGlashan TH, Srihari VH, Mathalon DH. Automatic auditory processing deficits in schizophrenia and clinical high-risk patients: forecasting psychosis risk with mismatch negativity. Biol Psychiatry. 2014 Mar 15;75(6):459-69. doi: 10.1016/j.biopsych.2013.07.038. Epub 2013 Sep 16.
PubMed 24050720Schmidt SJ, Schultze-Lutter F, Schimmelmann BG, Maric NP, Salokangas RK, Riecher-Rossler A, van der Gaag M, Meneghelli A, Nordentoft M, Marshall M, Morrison A, Raballo A, Klosterkotter J, Ruhrmann S. EPA guidance on the early intervention in clinical high risk states of psychoses. Eur Psychiatry. 2015 Mar;30(3):388-404. doi: 10.1016/j.eurpsy.2015.01.013. Epub 2015 Mar 3.
PubMed 25749390
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of N-acetylcysteine on Psychosis-like Symptoms and a Neurophysiological Biomarker of the Clinical High Risk for Schizophrenia
- ClinicalTrials.gov ID
- NCT05142735
- Acronym / sponsor ID
- 054-2020
- Conditions
- Prodromal Schizophrenia
- Keywords
- psychosis, schizophrenia, N-acetylcysteine, prodrome, mismatch negativity, event-related potentials, clinical high risk state
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim is to examine the effect of NAC on psychosis-like symptoms in CHR patients. Secondary aims are to examine the effect of NAC, in these patients, on the amplitude of the mismatch negativity (MMN), an electroencephalographic event-related potential (ERP) response to rare sounds among frequent ones; and the amplitude of the N400 semantic priming effect, an ERP response to unexpected compared to expected meaningful stimuli (e.g., words, pictures); both of which have been found to be reduced in both schizophrenia and the CHR state.
This will be a randomized, double-blind, placebo-controlled trial. Ninety CHR patients will take either NAC 2000 mg orally or placebo, daily for 8 weeks. Psychosis-like symptoms will be assessed at baseline, week 4 and week 8 using the Positive symptom score of the Scale of Psychosis-Risk Symptoms in the Structured Interview for Psychosis-Risk Syndromes. MMN amplitude and the N400 semantic priming effect will be measured at baseline and week 8. We hypothesize that patients will have more improvement in psychosis-like symptoms, and greater increases in MMN amplitudes and N400 semantic priming effects, after taking NAC vs. placebo. If we find that NAC improves psychosis-like symptoms and/or these neurophysiological biomarkers of the CHR state, this would support further research on NAC as a preventive treatment against psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of NAC or placebo groups in parallel for the duration of the study. This will be a randomized, double-blind, placebo-controlled trial. Participants will be randomized to take either NAC 2000 mg or placebo, in the form of oral capsules, every morning for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: N-AcetylcysteineN-Acetylcysteine 2000 mg (4 x 500-mg tablets) orally every morning for 8 weeks |
| Placebo Comparator | Placebo comparator | Dietary Supplement: PlaceboN-Acetylcysteine Placebo tablet matching N-Acetylcysteine orally every morning for 8 weeks |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
- concomitant or past neurological condition
- visual impairment which is not corrected to normal by prescription glasses history of reading disability
- past antipsychotic treatment at a therapeutic dose
- current treatment with a psychotropic medication except antidepressants on which the participants has been on a stable dose for at least 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-AcetylcysteineAlso: NAC2000 mg (4 x 500-mg tablets) every morning | Dietary supplement | Experimental |
| Placebo4 placebo tablets every morning | Dietary supplement | Placebo Comparator |
Primary outcome
Change in positive psychosis-like symptoms from baseline to 8 weeks
Time frame: Week 0 to week 8
Measured by the Positive symptom score of the Scale of Psychosis-Risk Symptoms, where the minimum score is 0 and the maximum score is 30, and higher scores mean a worse outcome.
2 secondary outcomes
Change in mismatch negativity (MMN) amplitude from baseline to 8 weeks
Time frame: Week 0 to week 8
Change in N400 semantic priming effect from baseline to 8 weeks
Time frame: Week 0 to week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 28730848Addington J, Addington D, Abidi S, Raedler T, Remington G. Canadian Treatment Guidelines for Individuals at Clinical High Risk of Psychosis. Can J Psychiatry. 2017 Sep;62(9):656-661. doi: 10.1177/0706743717719895. Epub 2017 Jul 21.
- Background: PubMed 22000060Atkinson RJ, Michie PT, Schall U. Duration mismatch negativity and P3a in first-episode psychosis and individuals at ultra-high risk of psychosis. Biol Psychiatry. 2012 Jan 15;71(2):98-104. doi: 10.1016/j.biopsych.2011.08.023. Epub 2011 Oct 13.
- Background: PubMed 29588126Breier A, Liffick E, Hummer TA, Vohs JL, Yang Z, Mehdiyoun NF, Visco AC, Metzler E, Zhang Y, Francis MM. Effects of 12-month, double-blind N-acetyl cysteine on symptoms, cognition and brain morphology in early phase schizophrenia spectrum disorders. Schizophr Res. 2018 Sep;199:395-402. doi: 10.1016/j.schres.2018.03.012. Epub 2018 Mar 24.
- Background: PubMed 25132466Cabungcal JH, Counotte DS, Lewis E, Tejeda HA, Piantadosi P, Pollock C, Calhoon GG, Sullivan E, Presgraves E, Kil J, Hong LE, Cuenod M, Do KQ, O'Donnell P. Juvenile antioxidant treatment prevents adult deficits in a developmental model of schizophrenia. Neuron. 2014 Sep 3;83(5):1073-1084. doi: 10.1016/j.neuron.2014.07.028. Epub 2014 Aug 14.
- Background: PubMed 29462456Conus P, Seidman LJ, Fournier M, Xin L, Cleusix M, Baumann PS, Ferrari C, Cousins A, Alameda L, Gholam-Rezaee M, Golay P, Jenni R, Woo TW, Keshavan MS, Eap CB, Wojcik J, Cuenod M, Buclin T, Gruetter R, Do KQ. N-acetylcysteine in a Double-Blind Randomized Placebo-Controlled Trial: Toward Biomarker-Guided Treatment in Early Psychosis. Schizophr Bull. 2018 Feb 15;44(2):317-327. doi: 10.1093/schbul/sbx093.
- Background: PubMed 23683390Flatow J, Buckley P, Miller BJ. Meta-analysis of oxidative stress in schizophrenia. Biol Psychiatry. 2013 Sep 15;74(6):400-9. doi: 10.1016/j.biopsych.2013.03.018. Epub 2013 May 15.
- Background: PubMed 22784684Hsieh MH, Shan JC, Huang WL, Cheng WC, Chiu MJ, Jaw FS, Hwu HG, Liu CC. Auditory event-related potential of subjects with suspected pre-psychotic state and first-episode psychosis. Schizophr Res. 2012 Sep;140(1-3):243-9. doi: 10.1016/j.schres.2012.06.021. Epub 2012 Jul 10.
- Background: PubMed 21740622Jahshan C, Cadenhead KS, Rissling AJ, Kirihara K, Braff DL, Light GA. Automatic sensory information processing abnormalities across the illness course of schizophrenia. Psychol Med. 2012 Jan;42(1):85-97. doi: 10.1017/S0033291711001061. Epub 2011 Jul 11.
- Background: PubMed 29036493Kim M, Lee TH, Yoon YB, Lee TY, Kwon JS. Predicting Remission in Subjects at Clinical High Risk for Psychosis Using Mismatch Negativity. Schizophr Bull. 2018 Apr 6;44(3):575-583. doi: 10.1093/schbul/sbx102.
- Background: PubMed 29132815Lavoie S, Jack BN, Griffiths O, Ando A, Amminger P, Couroupis A, Jago A, Markulev C, McGorry PD, Nelson B, Polari A, Yuen HP, Whitford TJ. Impaired mismatch negativity to frequency deviants in individuals at ultra-high risk for psychosis, and preliminary evidence for further impairment with transition to psychosis. Schizophr Res. 2018 Jan;191:95-100. doi: 10.1016/j.schres.2017.11.005. Epub 2017 Nov 11.
- Background: PubMed 30683525Lepock JR, Ahmed S, Mizrahi R, Gerritsen CJ, Maheandiran M, Drvaric L, Bagby RM, Korostil M, Light GA, Kiang M. Relationships between cognitive event-related brain potential measures in patients at clinical high risk for psychosis. Schizophr Res. 2020 Dec;226:84-94. doi: 10.1016/j.schres.2019.01.014. Epub 2019 Jan 22.
- Background: PubMed 14989408Miller TJ, McGlashan TH, Rosen JL, Cadenhead K, Cannon T, Ventura J, McFarlane W, Perkins DO, Pearlson GD, Woods SW. Prodromal assessment with the structured interview for prodromal syndromes and the scale of prodromal symptoms: predictive validity, interrater reliability, and training to reliability. Schizophr Bull. 2003;29(4):703-15. doi: 10.1093/oxfordjournals.schbul.a007040.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Kiang, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-Acetylcysteine in people with Prodromal Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Kiang, MD, PhD (416-535-8501 ext. 30337, michael.kiang@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in positive psychosis-like symptoms from baseline to 8 weeks (time frame: Week 0 to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05142735, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.