NCT04005053

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 15, 2023

Completed
Last Updated

August 15, 2023

Status Verified

July 1, 2023

Enrollment Period

2.8 years

First QC Date

June 27, 2019

Results QC Date

June 12, 2023

Last Update Submit

July 24, 2023

Conditions

Self-HarmDepressionSuicide

Outcome Measures

Primary Outcomes (1)

  • 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)

    28 days

Secondary Outcomes (2)

  • Change in GSH Reduced-to-oxidized Ratio

    28 days

  • Change in Glutamate Concentrations

    28 days

Study Arms (3)

Low-Dose NAC

EXPERIMENTAL

3600 NAC mg/day

Drug: N-acetyl cysteine

High-Dose NAC

EXPERIMENTAL

5400 NAC mg/day

Drug: N-acetyl cysteine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo oral tablet

Interventions

N-acetyl cysteineDRUG

3600 or 5400 mg/day N-acetyl cysteine

Also known as: N-acetylcysteine
High-Dose NACLow-Dose NAC
Placebo oral tabletDRUG

Placebo

Placebo

Eligibility Criteria

Age16 Years - 24 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Sahasrabudhe SA, Silamongkol T, Park YW, Colette A, Eberly LE, Klimes-Dougan B, Coles LD, Cloyd JC, Oz G, Mueller BA, Kartha RV, Cullen KR. Identifying Biological Signatures of N-Acetylcysteine for Non-Suicidal Self-Injury in Adolescents and Young Adults. J Psychiatr Brain Sci. 2021;6:e210007. doi: 10.20900/jpbs.20210007. Epub 2021 Apr 29.

    PMID: 34036177DERIVED

MeSH Terms

Conditions

Self-Injurious BehaviorDepressionSuicide

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Kathryn Cullen
Organization
University of Minnesota
rega0026@umn.edu
612-273-9732

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 2, 2019

Study Start

August 1, 2019

Primary Completion

May 8, 2022

Study Completion

October 1, 2022

Last Updated

August 15, 2023

Results First Posted

August 15, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)