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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Schizophrenic Psychoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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n-acetyl-cysteine

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

Group Type ACTIVE_COMPARATOR

n-acetylcysteine

Intervention Type DRUG

900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets are placed in water or juice in the AM and PM

Interventions

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n-acetylcysteine

900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM

Intervention Type DRUG

Placebo

Placebo tablets are placed in water or juice in the AM and PM

Intervention Type DRUG

Other Intervention Names

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PharmaNAC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No