Early Study of N-Acetylcysteine to Treat Deliberate Self-Harm in Adolescents

Completed · Phase 1

Conditions studied: Deliberate Self Harm

In brief

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.

Key facts

Study ID

NCT01111734

Run by

University of Minnesota

People needed

67

Starts

2011-03-01

Expected to finish

2015-05-01

Last updated by the study team

2019-05-01

Who can join

Age: 13 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All participants:
• Participants must be aged 13 years to 21 years with the ability to provide consent or guardian consent and assent.
• They must be available to come to the University of Minnesota for study visits.
• All DSH participants:
• Must have engaged in DSH at least 4 times, with most recent episode in past three months.
• Controls
• Have no history of deliberate self-harm
• Have no current or past psychiatric diagnoses

You may not qualify if…

• Those who are pregnant, breastfeeding, or who have a positive urine drug screen will not be included.
• Individuals with unstable medical illnesses, a history of seizures or heart attack, or arrhythmia not be included.
• Participants will not have a history of Bipolar type I or II, dementia, schizophrenia or any other psychotic disorder.
• Patients with active suicidal intent will not be included.
• If DSH participants are currently taking medications, the doses of these must be stable 1 month prior to study onset.
• For Receiving NAC:
• Participants may not be taking the following medications concurrently, due to the possibility of medication interactions: activated charcoal, ampicillin, carbamazepine, cephaloridine, cloxacillin, methicillin, nitroglycerin, oxacillin, penicillin G, quinacillin.
• Participants cannot have a history of allergic reaction to NAC.
• For MRI Scanning:
• Participants may not have any metal in their body that would be unsafe in an MRI scanner.
• Participants with claustrophobia will not be included.

Where it is running

• University of Minnesota Dept. of Psychiatry Ambulatory Research Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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