NCT01354132

N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis

Effects of Oral N-Acetyl-Cysteine (NAC) in the Early Phase of Schizophrenia Spectrum Psychosis: Randomized, Parallel, Double- Blind, Placebo Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. Therefore, studying new treatments that could target changes occurring during this period is of critical importance. Aims: Does add-on NAC treatment in early psychosis influence: * positive and negative symptoms * extrapyramidal side-effects of other medication * plasma concentration of glutathione * Mismatch Negativity, a physiological marker

Detailed description

The study proposes that a glutathione deficit leading to an abnormal response to oxidative stress is a vulnerability factor, combined with other brain specific factors, in brain functioning of some individuals with schizophrenia (Do et al., 2010). N-acetyl-cysteine is hypothesized to cross the blood-brain barrier and increase glutathione in the brain.

Conditions

• Schizophrenic Psychoses

Interventions

Type	Name	Description
DRUG	n-acetylcysteine	900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
DRUG	Placebo	Placebo tablets are placed in water or juice in the AM and PM

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2011-05-16
• Last updated: 2017-07-05
• Results posted: 2017-06-07

Locations

2 sites across 1 country: United States