Trial record 3 of 84 for:    Open Studies | "Self-Injurious Behavior"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01111734
First received: April 26, 2010
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Deliberate Self Harm
Dietary Supplement: N-Acetylcysteine
Drug: fMRI
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: N-Acetylcysteine in the Treatment of Deliberate Self-Harm in Adolescents: An Open Label Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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

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

  • Inventory of Statements about Self-Injury (ISAS) [ Time Frame: Every 2 weeks ] [ Designated as safety issue: Yes ]
    Questionnaire regarding self injurious behavior.


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

  • Barrett Impulsivity Scale (BIS) [ Time Frame: Intake, Exit ] [ Designated as safety issue: No ]
    This instrument will assess the effect of the intervention on impulsivity factors.

  • Deliberate Self-Harm Questionnaire-Mood (DSHQ-M) [ Time Frame: Intake ] [ Designated as safety issue: No ]
    Questionnaire regarding mood before, after, and during engaging in self-injurious behavior.

  • BDI-II [ Time Frame: Intake, Baseline MRI, Exit MRI ] [ Designated as safety issue: Yes ]
    Assesses depressive mood in last two weeks.

  • Iowa Gambling Task (IGT) [ Time Frame: Intake, Exit ] [ Designated as safety issue: No ]
    Game used to measure reward processing

  • Symptom Check-List 90 (SCL-90) [ Time Frame: Intake, Exit ] [ Designated as safety issue: No ]
    Looks at correlation between amygdala-thalamus connectivity and interpersonal sensitivity.

  • Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Intake, Exit ] [ Designated as safety issue: No ]
    Used to assess capacity for emotion regulation.

  • Children's Depression Rating Scale - Revised (CDRS-R) [ Time Frame: Intake ] [ Designated as safety issue: Yes ]
    A questionnaire that will help assess participant's depression

  • NIH Toolbox [ Time Frame: Intake ] [ Designated as safety issue: No ]
    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

  • Wechsler Abbreviated Scale of Intelligence (WASI-2) [ Time Frame: Intake ] [ Designated as safety issue: No ]
    Used to assess IQ

  • Tanner Questionnaire [ Time Frame: Intake ] [ Designated as safety issue: No ]
    This questionnaire will be used to assess pubertal stages of participants

  • Personality Assessment Inventory (PAI) [ Time Frame: Intake ] [ Designated as safety issue: No ]
    A multi-scale test of psychological functioning that assesses constructs relevant to personality and psychopathology evaluation.

  • Satisfaction with Life Scale [ Time Frame: Intake, Exit ] [ Designated as safety issue: No ]
    This questionnaire looks at the participants satisfaction with their life at the moment

  • Toronto Alexithymia Scale (TAS) [ Time Frame: Intake, Exit ] [ Designated as safety issue: No ]
    Will assess the presence or extent to which the participant exhibits Alexithymia.

  • Rejection Sensitivity Questionnaire - Adolescent (RSQ-A) [ Time Frame: Intake ] [ Designated as safety issue: No ]
    Assesses the extent to which the participant perceives rejection in their daily lives.

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


Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

Controls

  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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111734

Contacts
Contact: Tricia Carstedt, BA (612) 626-8534 triciac@umn.edu
Contact: Kathryn R Cullen, MD 612-273-9762 rega0026@umn.edu

Locations
United States, Minnesota
University of Minnesota Dept. of Psychiatry Ambulatory Research Center Recruiting
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Minnesota Medical Foundation
Investigators
Principal Investigator: Kathryn R Cullen, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01111734     History of Changes
Other Study ID Numbers: 0909M72855
Study First Received: April 26, 2010
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
self harm
self injury
self mutilation
N-Acetylcysteine
adolescents
impulse control disorder
borderline personality disorder
fMRI

Additional relevant MeSH terms:
Self-Injurious Behavior
Behavioral Symptoms
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014