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

Schizophrenic Psychoses Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenic Psychoses

• NCT number: NCT01354132
• Study type: Interventional
• Source: Beth Israel Deaconess Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: May 2011
• Completion date: August 2014