Deliberate Self Harm Clinical Trial
Official title:
N-Acetylcysteine in the Treatment of Deliberate Self-Harm in Adolescents: An Open Label Pilot Study
NCT number | NCT01111734 |
Other study ID # | 0909M72855 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | March 2011 |
Est. completion date | May 2015 |
Verified date | April 2019 |
Source | University of Minnesota - Clinical and Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 21 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Dept. of Psychiatry Ambulatory Research Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute | Minnesota Medical Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Deliberate Self Harm Inventory Clinical Change Version (DSHI-CCV) | Assesses frequency and type of deliberate self harm. | Every 2 weeks | |
Primary | 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 | |
Primary | Inventory of Statements about Self-Injury (ISAS) | Questionnaire regarding self injurious behavior. | Every 2 weeks | |
Secondary | Columbia Suicide Severity Rating Scale (CSSRS) | Measure of suicide risk to assess safety during the study. | Every 2 weeks | |
Secondary | Barrett Impulsivity Scale (BIS) | This instrument will assess the effect of the intervention on impulsivity factors. | Intake, Exit | |
Secondary | Deliberate Self-Harm Questionnaire-Mood (DSHQ-M) | Questionnaire regarding mood before, after, and during engaging in self-injurious behavior. | Intake | |
Secondary | BDI-II | Assesses depressive mood in last two weeks. | Intake, Baseline MRI, Exit MRI | |
Secondary | Iowa Gambling Task (IGT) | Game used to measure reward processing | Intake, Exit | |
Secondary | Symptom Check-List 90 (SCL-90) | Looks at correlation between amygdala-thalamus connectivity and interpersonal sensitivity. | Intake, Exit | |
Secondary | Difficulties in Emotion Regulation Scale (DERS) | Used to assess capacity for emotion regulation. | Intake, Exit | |
Secondary | Children's Depression Rating Scale - Revised (CDRS-R) | A questionnaire that will help assess participant's depression | Intake | |
Secondary | NIH Toolbox | 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 | Intake | |
Secondary | Wechsler Abbreviated Scale of Intelligence (WASI-2) | Used to assess IQ | Intake | |
Secondary | Tanner Questionnaire | This questionnaire will be used to assess pubertal stages of participants | Intake | |
Secondary | Personality Assessment Inventory (PAI) | A multi-scale test of psychological functioning that assesses constructs relevant to personality and psychopathology evaluation. | Intake | |
Secondary | Satisfaction with Life Scale | This questionnaire looks at the participants satisfaction with their life at the moment | Intake, Exit | |
Secondary | Toronto Alexithymia Scale (TAS) | Will assess the presence or extent to which the participant exhibits Alexithymia. | Intake, Exit | |
Secondary | Rejection Sensitivity Questionnaire - Adolescent (RSQ-A) | Assesses the extent to which the participant perceives rejection in their daily lives. | Intake | |
Secondary | Self-Injury Assessment Scale (SIAS) | Provides more information about the participant's self-harm behaviors over the past two weeks. | Every 2 weeks |
Status | Clinical Trial | Phase | |
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