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

NCT01111734 | Completed Phase 1 DMC

• 1 other identifier: 0909M72855
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deliberate Self Harm

Keywords

self harm; self injury; self mutilation; N-Acetylcysteine; adolescents; impulse control disorder; borderline personality disorder; fMRI

Outcome Measures

Primary Outcomes (3)

• Deliberate Self Harm Inventory Clinical Change Version (DSHI-CCV)

  Assesses frequency and type of deliberate self harm.

  Every 2 weeks

• K-SADS-PL

  A semi-structured clinical interview conducted separately with child and parent. Clinicians formulate the diagnosis during a consensus meeting, combining all clinical information.

  Intake

• Inventory of Statements about Self-Injury (ISAS)

  Questionnaire regarding self injurious behavior.

  Every 2 weeks

Secondary Outcomes (16)

• Columbia Suicide Severity Rating Scale (CSSRS)

  Every 2 weeks

• Barrett Impulsivity Scale (BIS)

  Intake, Exit

• Deliberate Self-Harm Questionnaire-Mood (DSHQ-M)

  Intake

• BDI-II

  Intake, Baseline MRI, Exit MRI

• Iowa Gambling Task (IGT)

  Intake, Exit

Study Arms (2)

Treatment Group

EXPERIMENTAL

The study consists of eight weeks of open label N-Acetylcysteine. All eligible study subjects will be treated with 600mg of N-Acetylcysteine twice a day for 2 weeks, then the dose will be increased to 1200mg twice a day for two weeks, and to 1800mg twice a day for 4 weeks. weeks. Subjects will be seen every two weeks during the 8-week study. Efficacy and safety assessments will be performed at each visit.

Dietary Supplement: N-Acetylcysteine; Drug: fMRI

Control

EXPERIMENTAL

40 healthy age-matched peers with undergo the same baseline testing as the NAC subjects as well as baseline fMRI. They will not engage in any follow up visits.

Drug: fMRI

Interventions

N-Acetylcysteine DIETARY_SUPPLEMENT

All eligible study subjects will be treated with 600mg of N-Acetylcysteine orally twice a day for 2 weeks, then the dose will be increased to 1200mg twice a day for two weeks, and to 1800mg twice a day for 4 weeks.

Also known as: NAC, N-Acetylcysteine, Brand: Swansons Vitamins, 600mg capsule

Treatment Group

fMRI DRUG

All eligible subjects and controls will undergo an emotional face-viewing task in our fMRI paradigm in order to focus in on the circuitry related to affect processing.

Also known as: Seimens 3T MRI

Control; Treatment Group

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• University of Minnesota: lead
• Minnesota Medical Foundation: collaborator

Study Sites (1)

University of Minnesota Dept. of Psychiatry Ambulatory Research Center

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Self-Injurious Behavior; Self Mutilation; Disruptive, Impulse Control, and Conduct Disorders; Borderline Personality Disorder

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Wounds and Injuries; Mental Disorders; Personality Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kathryn R Cullen, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 28, 2010
• Study Start: March 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

US (1)