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

Schizophrenic Psychoses Clinical Trial

— NACPSY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354132
• Other study ID #: 2008P-000460 BIDMC 42
• Secondary ID: 107865
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2011
• Last updated: May 26, 2015
• Start date: May 2011
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Capacity to provide informed consent

• DSM IV TR diagnosis of schizophrenia, schizophreniform, schizoaffective

• Psychiatric and medical stability

• Prescribing clinician's premission to participate, assurance of medical stability

• Having met threshold criteria for psychosis on CAARMS (Comprehensive Assessment of at Risk Mental States Scale) Psychosis subscale

• Up to 12 months of antipsychotic treatment

Exclusion Criteria:

• Severe medical comorbidities

• Previous cerebral trauma

• Substance induced psychosis or organic psychosis

• Mental retardation

• NAC allergy

• Pregnancy, females and males planning pregnancy

• Treatment with antioxidants

• Insufficient command of English

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

Intervention

Drug:
• n-acetylcysteine
900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts Mental Health Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Center de Neurosciences Psychiatrique, Lausanne, Switzerland

Country where clinical trial is conducted

United States, 

References & Publications (1)

Do KQ, Conus P, Cuenod M. Redox dysregulation and oxidative stress in schizophrenia: nutrigenetics as a challenge in psychiatric disease prevention. World Rev Nutr Diet. 2010;101:131-53. doi: 10.1159/000314518. Epub 2010 Apr 30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of negative symptoms on the PANSS	Positive and Negative Syndrome Scale	within 6 months of NAC treatment	No
Secondary	Improved positive and general symptoms (PANSS) and functional level (GAF & SOFAS)	Positive and Negative Syndrome Scale Global Assessment of Functioning Social and Occupational Functioning Assessment Scale	within 6 months of NAC treatment	No
Secondary	Improved cognition and working memory (MATRICS)	The MATRICS is neurocognitive battery designed to assess cognition in psychopharmacology studies	at 24 weeks of NAC treatment	No
Secondary	Improved EEG/Evoked potentials (Mismatch Negativity)	Mismatch Negativity, a component of auditory evoked potentials	at 24 weeks of NAC treatment	No
Secondary	Improved plasma glutathione	Plasma levels of glutathione, plasma amino acids and genetic analysis of enzymes involved in glutathione metabolism	within 24 weeks of NAC treatment	No