Clinical trial NCT01354132: N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis
Official title: Effects of Oral N-Acetyl-Cysteine (NAC) in the Early Phase of Schizophrenia Spectrum Psychosis: Randomized, Parallel, Double- Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenic Psychoses
Keywords: schizophrenia
schizoaffective
schizophreniform
early schizophrenia spectrum psychosis
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Center de Neurosciences Psychiatrique, Lausanne, Switzerland
First posted: 2011-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change in Negative Symptoms of Schizophrenia as Measured on the PANSS
timeFrame: at 6 months
Secondary outcomes:
measure: Change in Positive Symptoms (PANSS)
timeFrame: at 6 months
measure: Global Assessment of Functioning (GAF)
timeFrame: at 6 months
measure: Social and Occupational Functioning Assessment Scale (SOFAS)
timeFrame: at 6 months
measure: Change in Cognition and Working Memory (MATRICS) Speed of Processing
timeFrame: at 6 months
measure: Change in Cognition and Working Memory (MATRICS) Working Memory
timeFrame: at 6 months
measure: Change in Cognition and Working Memory (MATRICS) Attention and Vigilance
timeFrame: at 6 months
measure: Change in Cognition and Working Memory (MATRICS) Verbal Learning
timeFrame: at 6 months
measure: Change in Cognition and Working Memory (MATRICS) Visual Learning
timeFrame: at 6 months
measure: Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving
timeFrame: at 6 months
measure: Change in Blood Level of Glutathione
timeFrame: at 6 months
measure: Blood Plasma Level of Cysteine
timeFrame: at 6 months
measure: GPxbc Glutathione Peroxidase Activity in Blood Cells
timeFrame: at 6 months
measure: Glutamine Brain Level for NAC Group
timeFrame: at 6 months
measure: Glutamine Brain Level for Placebo Group
timeFrame: at 6 months
measure: Glutamate Brain Level for NAC Group
timeFrame: at 6 months
measure: Glutamate Brain Level for Placebo Group
timeFrame: at 6 months
measure: Glutathione Brain Level for NAC Group
timeFrame: at 6 months
measure: Glutathione Brain Level for Placebo Group
timeFrame: at 6 months
measure: Myo-Inositol Brain Level for the NAC Group
timeFrame: at 6 months
measure: Myo-Inositol Brain Level for Placebo Group
timeFrame: at 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts Mental Health Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Ann Cousins, PhD, APRN
role: STUDY_DIRECTOR
affiliation: Harvard Medical School (HMS and HSDM)
name: T. U. Wilson Woo, MD, PhD
role: STUDY_CHAIR
References:
citation: 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;101:131-153. doi: 10.1159/000314518. Epub 2010 Apr 30. No abstract available.