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
  Purpose

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

Condition Intervention Phase
Schizophrenic Psychoses
Drug: n-acetylcysteine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Oral N-Acetyl-Cysteine (NAC) in the Early Phase of Schizophrenia Spectrum Psychosis: Randomized, Parallel, Double- Blind, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 33
Study Start Date: May 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: n-acetyl-cysteine Drug: n-acetylcysteine
900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
Other Name: PharmaNAC
Placebo Comparator: Placebo Drug: n-acetylcysteine
900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
Other Name: PharmaNAC

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354132

Contacts
Contact: Corin Pilo, MA 617-998-5016 cpilo@bidmc.harvard.edu
Contact: Ann Cousins, PhD, APRN 617-626-9381 acousins@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Sub-Investigator: T. U. Wilson Woo, MD, PhD         
Massachusetts Mental Health Center Recruiting
Boston, Massachusetts, United States, 02215
Sub-Investigator: T. U. Wilson Woo, MD, PhD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Center de Neurosciences Psychiatrique, Lausanne, Switzerland
Investigators
Study Director: Ann Cousins, PhD, APRN Beth Israel Deaconess Medical Center
Study Chair: T. U. Wilson Woo, MD, PhD Harvard Medical School
  More Information

Publications:
Responsible Party: Larry J. Seidman, Ph.D., Beth Israel Deaconess Medical Center, Commonwealth Research Center
ClinicalTrials.gov Identifier: NCT01354132     History of Changes
Other Study ID Numbers: BIDMC 42, 107865
Study First Received: May 13, 2011
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
schizophrenia
schizoaffective
schizophreniform
early schizophrenia spectrum psychosis

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on April 16, 2014