CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
n-acetylcysteine +1 moredrug
Likely dose
n-acetylcysteine 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01354132
NCT01354132Phase 2Completed

Effects of Oral N-Acetyl-Cysteine (NAC) in the Early Phase of Schizophrenia Spectrum Psychosis: Randomized, Parallel, Double- Blind, Placebo Controlled Trial

Beth Israel Deaconess Medical Center·interventional·Posted May 16, 2011·Updated Jul 5, 2017

In Brief

A Phase 2 clinical trial evaluating n-acetylcysteine and Placebo for Schizophrenic Psychoses. Completed, enrolled 20 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2011
Enrollment StartMay 1, 2011
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.1 years ago

Interventions

n-acetylcysteinedrug

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

Placebodrug

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