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

Phase 2

Completed

• Conditions: Self-Harm; Depression; Suicide
• Interventions: Drug: N-acetyl cysteine; Drug: Placebo oral tablet

• Registration Number: NCT04005053
• Lead Sponsor: University of Minnesota

Brief Summary

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).

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-07-02
• Study Start: 2019-08-01
• Primary Completion: 2022-05-08
• Study Completion: 2022-10-01
• Results First Submitted: 2023-06-12
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Results First Posted: 2023-08-15
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Dose NAC	N-acetyl cysteine	3600 NAC mg/day
High-Dose NAC	N-acetyl cysteine	5400 NAC mg/day
Placebo	Placebo oral tablet	Placebo

Primary Outcome Measures

Name	Time	Method
Percent Increase in Glutathione (GSH) Concentrations in the ACC	28 days	increase in glutathione (GSH) concentrations in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS)

Secondary Outcome Measures

Name	Time	Method
Change in GSH Reduced-to-oxidized Ratio	28 days	Percent increase in reduced-to-oxidized ratio of glutathione (GSH) in the blood compared to baseline
Change in Glutamate Concentrations	28 days	Percent decrease in the concentrations of glutamate (GLU) in the anterior cingulate cortex (ACC) measured by MRS

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States