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Treatment of Cognitive and Negative Symptoms in Schizophrenia With N-acetylcysteine (NAC2 Trial)
Phase 4
Waitlist Available
Led By Yvonne Yang, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 weeks (baseline), 4 weeks and 8 weeks of treatment with nac
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
Summary
This trial aims to treat cognitive and negative symptoms in schizophrenia patients using the dietary supplement N-acetylcysteine (NAC). Schizophrenia patients often struggle with memory, attention, and social interaction issues, which current treatments do not address well. NAC may help by balancing brain chemicals and protecting against damage, potentially improving these symptoms. N-Acetylcysteine (NAC) has been studied for schizophrenia, showing potential benefits for negative symptoms and cognitive impairments.
Eligible Conditions
- Schizophrenia
- Avolition
- Memory Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 weeks (baseline), 4 weeks and 8 weeks of treatment with nac
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 weeks (baseline), 4 weeks and 8 weeks of treatment with nac
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Glutamate levels in prefrontal cortex
Glutathione levels in prefrontal cortex
Improvement of negative symptoms
Other study objectives
Cognitive Performance on the MCCB
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: N-acetylcysteineExperimental Treatment2 Interventions
Patients in this group will receive N-acetylcysteine (NAC) 1200mg orally twice daily (total daily dose 2400mg), for eight weeks. Each individual tablet contains 300mg NAC, therefore patients will take two tablets by mouth each morning and two tablets by mouth each evening. Manufacturer: Jarrow Industries, Inc.; Brand name: N-A-C Sustain
Group II: PlaceboPlacebo Group1 Intervention
Patients in this group will receive placebo tablets indistinguishable from NAC tablets, with the same protocol as NAC: two placebo tablets by mouth each morning, and two placebo tablets by mouth each evening. Manufacturer: Jarrow Industries, Inc.; Brand name: N-A-C Sustain
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cysteine
FDA approved
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,567 Previous Clinical Trials
10,266,949 Total Patients Enrolled
38 Trials studying Schizophrenia
4,816 Patients Enrolled for Schizophrenia
Yvonne Yang, MD, PhDPrincipal InvestigatorAssistant Clinical Professor