N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 7/11/2015 |
| Start Date: | May 2011 |
| End Date: | May 2017 |
| Contact: | Corin Pilo, MA |
| Email: | cpilo@bidmc.harvard.edu |
| Phone: | 617-998-5016 |
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
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.
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.
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
We found this trial at
2
sites
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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