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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01111734
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : May 1, 2019
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Deliberate Self Harm Dietary Supplement: N-Acetylcysteine Drug: fMRI Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: N-Acetylcysteine in the Treatment of Deliberate Self-Harm in Adolescents: An Open Label Pilot Study
Study Start Date : March 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm

Arm Intervention/treatment
Experimental: Treatment Group
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
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.
Other Names:
  • NAC, N-Acetylcysteine
  • Brand: Swansons Vitamins
  • 600mg capsule

Drug: fMRI
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.
Other Name: Seimens 3T MRI

Experimental: Control
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
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.
Other Name: Seimens 3T MRI

Primary Outcome Measures :
  1. Deliberate Self Harm Inventory Clinical Change Version (DSHI-CCV) [ Time Frame: Every 2 weeks ]
    Assesses frequency and type of deliberate self harm.

  2. K-SADS-PL [ Time Frame: Intake ]
    A semi-structured clinical interview conducted separately with child and parent. Clinicians formulate the diagnosis during a consensus meeting, combining all clinical information.

  3. Inventory of Statements about Self-Injury (ISAS) [ Time Frame: Every 2 weeks ]
    Questionnaire regarding self injurious behavior.

Secondary Outcome Measures :
  1. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Every 2 weeks ]
    Measure of suicide risk to assess safety during the study.

  2. Barrett Impulsivity Scale (BIS) [ Time Frame: Intake, Exit ]
    This instrument will assess the effect of the intervention on impulsivity factors.

  3. Deliberate Self-Harm Questionnaire-Mood (DSHQ-M) [ Time Frame: Intake ]
    Questionnaire regarding mood before, after, and during engaging in self-injurious behavior.

  4. BDI-II [ Time Frame: Intake, Baseline MRI, Exit MRI ]
    Assesses depressive mood in last two weeks.

  5. Iowa Gambling Task (IGT) [ Time Frame: Intake, Exit ]
    Game used to measure reward processing

  6. Symptom Check-List 90 (SCL-90) [ Time Frame: Intake, Exit ]
    Looks at correlation between amygdala-thalamus connectivity and interpersonal sensitivity.

  7. Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Intake, Exit ]
    Used to assess capacity for emotion regulation.

  8. Children's Depression Rating Scale - Revised (CDRS-R) [ Time Frame: Intake ]
    A questionnaire that will help assess participant's depression

  9. NIH Toolbox [ Time Frame: Intake ]
    The NIH tool box is compromised of 2 computer-based measures: the Flanker Task, and the Dimensional Card Sort Test. The participant will complete both measures. These will measure neurocognitive functioning

  10. Wechsler Abbreviated Scale of Intelligence (WASI-2) [ Time Frame: Intake ]
    Used to assess IQ

  11. Tanner Questionnaire [ Time Frame: Intake ]
    This questionnaire will be used to assess pubertal stages of participants

  12. Personality Assessment Inventory (PAI) [ Time Frame: Intake ]
    A multi-scale test of psychological functioning that assesses constructs relevant to personality and psychopathology evaluation.

  13. Satisfaction with Life Scale [ Time Frame: Intake, Exit ]
    This questionnaire looks at the participants satisfaction with their life at the moment

  14. Toronto Alexithymia Scale (TAS) [ Time Frame: Intake, Exit ]
    Will assess the presence or extent to which the participant exhibits Alexithymia.

  15. Rejection Sensitivity Questionnaire - Adolescent (RSQ-A) [ Time Frame: Intake ]
    Assesses the extent to which the participant perceives rejection in their daily lives.

  16. Self-Injury Assessment Scale (SIAS) [ Time Frame: Every 2 weeks ]
    Provides more information about the participant's self-harm behaviors over the past two weeks.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

All participants:

  1. Participants must be aged 13 years to 21 years with the ability to provide consent or guardian consent and assent.
  2. They must be available to come to the University of Minnesota for study visits.

All DSH participants:

1) Must have engaged in DSH at least 4 times, with most recent episode in past three months.


  1. Have no history of deliberate self-harm
  2. Have no current or past psychiatric diagnoses

Exclusion Criteria:

  1. Those who are pregnant, breastfeeding, or who have a positive urine drug screen will not be included.
  2. Individuals with unstable medical illnesses, a history of seizures or heart attack, or arrhythmia not be included.
  3. Participants will not have a history of Bipolar type I or II, dementia, schizophrenia or any other psychotic disorder.
  4. Patients with active suicidal intent will not be included.
  5. If DSH participants are currently taking medications, the doses of these must be stable 1 month prior to study onset.

For Receiving NAC:

  1. 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.
  2. Participants cannot have a history of allergic reaction to NAC.

For MRI Scanning:

  1. Participants may not have any metal in their body that would be unsafe in an MRI scanner.
  2. Participants with claustrophobia will not be included.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01111734

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United States, Minnesota
University of Minnesota Dept. of Psychiatry Ambulatory Research Center
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
Minnesota Medical Foundation
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Principal Investigator: Kathryn R Cullen, MD University of Minnesota

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Responsible Party: University of Minnesota Identifier: NCT01111734     History of Changes
Other Study ID Numbers: 0909M72855
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Keywords provided by University of Minnesota:
self harm
self injury
self mutilation
impulse control disorder
borderline personality disorder
Additional relevant MeSH terms:
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Self Mutilation
Self-Injurious Behavior
Behavioral Symptoms
Wounds and Injuries
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs