Phase 2
Completed N=44
Signatures of N-Ac for Non-Suicidal Self-Injury in Adolescents
Self-Harm · Depression · Suicide
Source: ClinicalTrials.gov NCT04005053 ↗
Enrolled (actual)
44
Serious AEs
2.6%
Results posted
Aug 2023
Primary outcomePrimary: Percent Increase in Glutathione (GSH) Concentrations in the ACC — 5; 0; 2 Percent change
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Increase in Glutathione (GSH) Concentrations in the ACC |
5; 0; 2 | — |
| SECONDARY Change in GSH Reduced-to-oxidized Ratio |
14; 28; -5 | — |
| SECONDARY Change in Glutamate Concentrations |
-0.9; -1.2; -0.8 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04005053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.