Clinical trial

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

Name
PSYCH-2018-26890
Description
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).
Trial arms
Trial start
2019-08-01
Estimated PCD
2022-05-08
Trial end
2022-10-01
Status
Completed
Phase
Early phase I
Treatment
N-acetyl cysteine
3600 or 5400 mg/day N-acetyl cysteine
Arms:
High-Dose NAC, Low-Dose NAC
Other names:
N-acetylcysteine
Placebo oral tablet
Placebo
Arms:
Placebo
Size
44
Primary endpoint
Percent Increase in Glutathione (GSH) Concentrations in the ACC
28 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 44, 'type': 'ACTUAL'}}
Updated at
2023-08-15

1 organization

2 products

3 indications

Indication
Suicide
Product
Placebo