Signatures of N-Ac for Non-Suicidal Self-Injury in Adolescents

University of Minnesota44 enrolled

Overview

To measure NAC-induced changes to concentrations of glutathione (GSH) in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS) in 36 adolescents and young adults with NSSI (12 in each group: high, low, and placebo).

This study is a double-blind, placebo controlled, 4-week course of two-tiered N-acetylcysteine (NAC) dosing focused on identifying the optimal dose to achieve meaningful change in measurable biomarkers (glutathione and glutamate). This design will allow us to confirm acute biological changes, select the optimal dose for achieving biological effects, and examine dose/concentration-response relationships with respect to biological markers and pharmacokinetics. Brief schedule of activities: Subjects will be recruited through community and clinical settings and screened over the phone. There will be a total of 4 in-person visits and two sets of on-line study activities. Eligible participants will be assigned to one of 3 groups (double-blinded): a low-dose NAC group (3600 mg/day), a high-dose NAC group (5400mg/day), and placebo (PBO). The study intervention period is 4 weeks. Total participation is up to 8 weeks, depending on the length of time between Day 0 and Day 1. The investigators will recruit 36 adolescents and young adults aged 16-24 years. There will be 12 participants in each group (PBO, 3600mg/day, 5400mg/day). The investigators will use a minimization procedure to ensure that the participants in these 3 groups will have similar age, clinical severity and medication status.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Self-Harm Depression Suicide

Interventions

N-acetyl cysteineDRUG

3600 or 5400 mg/day N-acetyl cysteine

Placebo oral tabletDRUG

Placebo

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 24 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Current frequency of at least one NSSI episode in the past 2 months * ≥ 5 past episodes of NSSI with significant tissue damage (e.g. scars present) * Psychotropic medications are dose-stable for 1 month * Ability to understand study procedures and to comply with them for the entire length of the study Exclusion Criteria: * Any MRI contraindications (e.g. metal plates, claustrophobia, braces, implanted devices) * Any current serious medical illness as defined by medical history * Current Substance Use Disorder (except Tobacco Use Disorder) * Primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder) * Neurodevelopmental disorder such as mental retardation or autism * Changes in psychotropic medications in past 1 month * Taken NAC or glutathione on a regular basis in the past 6 months * Currently pregnant, planning to become pregnant, currently breastfeeding, or unwillingness to use contraception throughout the study. * Allergy/sensitivity to N-acetylcysteine. * Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Percent Increase in Glutathione (GSH) Concentrations in the ACC

increase in glutathione (GSH) concentrations in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS)

Time frame: 28 days

Secondary Outcomes

Change in GSH Reduced-to-oxidized Ratio

Percent increase in reduced-to-oxidized ratio of glutathione (GSH) in the blood compared to baseline

Time frame: 28 days

Change in Glutamate Concentrations

Percent decrease in the concentrations of glutamate (GLU) in the anterior cingulate cortex (ACC) measured by MRS

Time frame: 28 days

Data from ClinicalTrials.gov

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