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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 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to week 8 for reporting.

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 • NCT01675661
7%
Headache
5%
Nausea
5%
Diarrhea
2%
Abdominal discomfort
2%
Dyspepsia
2%
Pruritis
1%
Road traffic accident
1%
Alcohol abuse
1%
Arthropod bite
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
358 Previous Clinical Trials
81,165 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

N-Acetylcysteine (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT05142735 — N/A
Schizophrenia Research Study Groups: Experimental, Placebo Comparator
Schizophrenia Clinical Trial 2023: N-Acetylcysteine Highlights & Side Effects. Trial Name: NCT05142735 — N/A
N-Acetylcysteine (Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05142735 — N/A
~17 spots leftby Nov 2024
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