@article{ref1,
title="Identifying biological signatures of n-acetylcysteine for non-suicidal self-injury in adolescents and young adults",
journal="Journal of psychiatry and brain science",
year="2021",
author="Sahasrabudhe, Siddhee A. and Silamongkol, Thanharat and Park, Young Woo and Colette, Alanna and Eberly, Lynn E. and Klimes-Dougan, Bonnie and Coles, Lisa D. and Cloyd, James C. and Öz, Gülin and Mueller, Bryon A. and Kartha, Reena V. and Cullen, Kathryn R.",
volume="6",
number="",
pages="e20210007-e20210007",
abstract="The prevalence of non-suicidal self-injury (NSSI) is high in adolescents and young adults. However, there is a paucity of evidence-based treatments to address this clinical problem. An open-label, pilot study in the target population showed that treatment with oral N-acetylcysteine (NAC), a widely available dietary supplement, was associated with reduction in NSSI frequency. In preparation for a biologically informed design of an efficacy trial, a critical preliminary step is to clarify NAC's biological signatures, or measures of the mechanisms underlying its clinical effects. Toward that end, we propose a 2-stage project to investigate NAC's biological signatures (changes in glutathione (GSH) and/or glutamate (Glu)) in women with NSSI. The first stage; a double-blind randomized placebo-controlled study will focus on identifying the optimal dose to achieve meaningful change in GSH and Glu during short-term (4 weeks) NAC treatment in 36 women aged 16-24 years with NSSI. Go/No-go criteria to determine if the study will progress to the second stage include pre-specified changes in brain and blood measures of GSH. Changes in the brain GSH are measured through magnetic resonance spectroscopy (MRS). The dose for the stage 2 will be selected based on the biological changes and the tolerability observed in the stage 1. The stage 2 will seek to replicate the biological signature findings in an 8-week trial in a new patient cohort, and examine the relationships among biological signatures, NAC pharmacokinetics and clinical response. This 2-stage project is unique as it unifies clinical psychiatric measurements, quantitative MRS and pharmacological approaches in the first placebo-controlled clinical trial of NAC in young women with NSSI. TRIAL REGISTRATION: The stage 1 trial protocol has been registered on https://clinicaltrials.gov/ with ClinicalTrials.gov ID &quot;NCT04005053&quot; (Registered on 02 July 2019. Available from: https://clinicaltrials.gov/ct2/show/NCT04005053).<p /> <p>Language: en</p>",
language="en",
issn="2398-385X",
doi="10.20900/jpbs.20210007",
url="http://dx.doi.org/10.20900/jpbs.20210007"
}