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

NCT01354132 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-07-05

Study results available
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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

Conditions

  • Schizophrenic Psychoses

Interventions

DRUG

n-acetylcysteine

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Ann Cousins, PhD, APRN · Beth Israel Deaconess Medical Center

  • T. U. Wilson Woo, MD, PhD · Harvard Medical School (HMS and HSDM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01354132 on ClinicalTrials.gov