Effects of NAC on Symptoms of CHR Patients
ConditionProdromal Schizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-35
SponsorCentre for Addiction and Mental Health
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
N-Acetylcysteine
Dietary supplement2000 mg (4 x 500-mg tablets) every morning
Placebo
Dietary supplement4 placebo tablets every morning
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 0 to week 8Secondary outcomes
1
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.
Time frame
Week 0 to week 82
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.
Time frame
Week 0 to week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov