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N-acetylcysteine for Schizophrenia (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks (baseline), 4 weeks and 8 weeks of treatment with nac for reporting.

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

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