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NCT01111734 · ClinicalTrials.gov registry record · Phase 1
Early Study of N-Acetylcysteine to Treat Deliberate Self-Harm in Adolescents
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT01111734 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 67 participants.
The verdict
NCT01111734, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
Deliberate Self-Harm (DSH) among adolescents is a serious behavioral problem associated with significant injury, impaired functioning, reduced quality of life, and high rates of psychiatric hospitalizations. While DSH has not been shown to have a direct link to suicide attempts themselves, there is a clear link between individuals who engage in DSH and overall rates of suicide. There is currently no medication treatment approved by the FDA for the treatment of DSH. The goal of this study is to evaluate the efficacy and safety of the dietary supplement N-Acetylcysteine in adolescents aged 13-21 with deliberate self-harm behaviors. There will be an additional neuroimaging component to expand knowledge regarding the neural correlates of this treatment in the study population. We hypothesize that N-Acetylcysteine will reduce the severity of deliberate self harm behaviors because this supplement has been helpful in treating disorders that share some similar traits with DSH. We will be using this medication in 40 young people who deliberately harm themselves and we will assess the severity of their behaviors while being treated with this dietary supplement. We also will collect neuroimaging data on the study participants at baseline and after the treatment with N-Acetylcysteine and compare it to 40 age-matched healthy peer neuroimaging data. The purpose of including this healthy group is to expand knowledge about neural correlates of the study population prior to treatment.
Interventions
- DIETARY_SUPPLEMENT N-Acetylcysteine
- DRUG fMRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01111734
The ClinicalTrials.gov registry entry for NCT01111734 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which N-Acetylcysteine is the first listed.
NCT01111734 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01111734 about?
NCT01111734 is a clinical study titled "Early Study of N-Acetylcysteine to Treat Deliberate Self-Harm in Adolescents". Deliberate Self-Harm (DSH) among adolescents is a serious behavioral problem associated with significant injury, impaired functioning, reduced quality of life, and high rates of psychiatric hospitalizations. While DSH has not been shown to have a direct link to suicide attempts themselves, there is ...
What is the current status of trial NCT01111734?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2011-03. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01111734?
The interventions under investigation include: N-Acetylcysteine (DIETARY_SUPPLEMENT), fMRI (DRUG).
Who is sponsoring clinical trial NCT01111734?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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