NCT04005053

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

Identifying Biological Signatures of N-Acetylcysteine for Non-Suicidal Self-Injury in Adolescents and Young Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Female
• Age: 16 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Self-Harm
• Depression
• Suicide

Interventions

Type	Name	Description
DRUG	N-acetyl cysteine	3600 or 5400 mg/day N-acetyl cysteine
DRUG	Placebo oral tablet	Placebo

Timeline

• Start date: 2019-08-01
• Primary completion: 2022-05-08
• Completion: 2022-10-01
• First posted: 2019-07-02
• Last updated: 2023-08-15
• Results posted: 2023-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study