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

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: Schizophrenic Psychoses

Treatments: Drug: n-acetylcysteine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01354132

2008P000460

107865 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

n-acetyl-cysteine

Active Comparator group

Description:

N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks

Treatment:

Drug: n-acetylcysteine

Placebo

Placebo Comparator group

Description:

matching effervescent tablets in water 2 in am and 1 in pm

Treatment:

Drug: Placebo