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Antioxidant
NAC for Schizophrenia
N/A
Recruiting
Led By Michael Kiang, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to week 8
Awards & highlights
Study Summary
This trial suggests that NAC, a precursor of an antioxidant, may reduce symptoms and brain abnormalities in people with early signs of schizophrenia.
Who is the study for?
This trial is for individuals showing early symptoms similar to schizophrenia, known as 'clinical high-risk' (CHR) symptoms. Participants must be able to consent and if female, either not of child-bearing potential or agree to use birth control. Exclusions include visual impairment not corrected by glasses, other DSM-5 diagnoses except some disorders in remission, pregnancy or intent thereof, breastfeeding plans, certain neurological conditions or treatments.Check my eligibility
What is being tested?
The study tests whether N-Acetylcysteine (NAC), an antioxidant that may help with brain health by reducing oxidative stress, can alleviate CHR symptoms compared to a placebo. The idea is that boosting the body's antioxidants might prevent psychosis in people at risk.See study design
What are the potential side effects?
While NAC is generally considered safe and well-tolerated based on previous studies for schizophrenia treatment, potential side effects could include gastrointestinal discomforts such as nausea or diarrhea and possibly allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 to week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in positive psychosis-like symptoms from baseline to 8 weeks
Secondary outcome measures
Change in N400 semantic priming effect from baseline to 8 weeks
Change in mismatch negativity (MMN) amplitude from baseline to 8 weeks
Side effects data
From 2015 Phase 3 trial • 302 Patients • NCT016756617%
Headache
5%
Nausea
5%
Diarrhea
2%
Abdominal discomfort
2%
Dyspepsia
2%
Pruritis
1%
Arthropod bite
1%
Road traffic accident
1%
Alcohol abuse
1%
Cellulitis
1%
Gastrointestinal disorder
1%
Abdominal pain
1%
Vomiting
1%
Reflux disease
1%
Dizziness
1%
Insomnia
1%
Rash
1%
Energy increased
1%
Groin Abscess
1%
Flushing
1%
Fatigue
1%
Panic attack
1%
Depression
1%
Blood pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
NAC Plus CM
Placebo Plus CM
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
N-Acetylcysteine 2000 mg (4 x 500-mg tablets) orally every morning for 8 weeks
Group II: Placebo ComparatorPlacebo Group1 Intervention
N-Acetylcysteine Placebo tablet matching N-Acetylcysteine orally every morning for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-Acetylcysteine
2013
Completed Phase 3
~1470
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,368 Total Patients Enrolled
58 Trials studying Schizophrenia
4,141 Patients Enrolled for Schizophrenia
Michael Kiang, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been identified as at risk for psychosis.I am currently taking nitroglycerin.I am on a stable dose of antidepressants for over 30 days.I have a current or past neurological condition.I am either not able to have children or will use birth control during the study.I have taken antipsychotic medication at a prescribed dose before.I am pregnant or planning to become pregnant.I understand the information given and can make decisions about my health care.I have had kidney stones in the past.I am currently taking an antibiotic.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
- Group 2: Placebo Comparator
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial accommodate individuals aged 55 or above?
"This trial demands that patients be between 16 and 35 years of age in order to participate, as dictated by the inclusion criteria."
Answered by AI
To which demographic is eligibility for this investigation open?
"To be eligible for this medical trial, individuals must have schizophrenia and should fall between the ages of 16 to 35. This experiment is searching for a sum total of 90 participants."
Answered by AI
Are researchers still seeking participants for this experiment?
"The clinical trial is currently open for applicants, as indicated on clinicaltrials.gov - the original posting was in January of 2023 and the most recent update occurred at the end of August."
Answered by AI
What is the current enrollment rate for this experiment?
"Affirmative. Information found on clinicaltrials.gov indicates that this study is currently enrolling participants - the trial was first posted on January 13th 2023 and last updated on August 29th of the same year. A total of 90 patients are required for this single-site experiment."
Answered by AI
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