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

This study is currently recruiting participants.
Verified May 2011 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
Center de Neurosciences Psychiatrique, Lausanne, Switzerland
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01354132
First received: May 13, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted

May 13, 2011
May 13, 2011
May 2011
May 2014   (final data collection date for primary outcome measure)
Improvement of negative symptoms on the PANSS [ Time Frame: within 6 months of NAC treatment ] [ Designated as safety issue: No ]
Positive and Negative Syndrome Scale
Same as current
No Changes Posted
  • Improved positive and general symptoms (PANSS) and functional level (GAF & SOFAS) [ Time Frame: within 6 months of NAC treatment ] [ Designated as safety issue: No ]
    Positive and Negative Syndrome Scale Global Assessment of Functioning Social and Occupational Functioning Assessment Scale
  • Improved cognition and working memory (MATRICS) [ Time Frame: at 24 weeks of NAC treatment ] [ Designated as safety issue: No ]
    The MATRICS is neurocognitive battery designed to assess cognition in psychopharmacology studies
  • Improved EEG/Evoked potentials (Mismatch Negativity) [ Time Frame: at 24 weeks of NAC treatment ] [ Designated as safety issue: No ]
    Mismatch Negativity, a component of auditory evoked potentials
  • Improved plasma glutathione [ Time Frame: within 24 weeks of NAC treatment ] [ Designated as safety issue: No ]
    Plasma levels of glutathione, plasma amino acids and genetic analysis of enzymes involved in glutathione metabolism
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Schizophrenic Psychoses
Drug: n-acetylcysteine
900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
Other Name: PharmaNAC
  • Active Comparator: n-acetyl-cysteine
    Intervention: Drug: n-acetylcysteine
  • Placebo Comparator: Placebo
    Intervention: Drug: n-acetylcysteine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
33
May 2017
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
No
Contact: Corin Pilo, MA 617-998-5016 cpilo@bidmc.harvard.edu
Contact: Ann Cousins, PhD, APRN 617-626-9381 acousins@bidmc.harvard.edu
United States
 
NCT01354132
BIDMC 42, 107865
Yes
Larry J. Seidman, Ph.D., Beth Israel Deaconess Medical Center, Commonwealth Research Center
Beth Israel Deaconess Medical Center
Center de Neurosciences Psychiatrique, Lausanne, Switzerland
Study Director: Ann Cousins, PhD, APRN Beth Israel Deaconess Medical Center
Study Chair: T. U. Wilson Woo, MD, PhD Harvard Medical School
Beth Israel Deaconess Medical Center
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP