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

2014-07-23 21:09:25 | BioPortfolio

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 16-21 with deliberate self-harm behaviors. 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 10 adolescents who deliberately harm themselves and we will assess the severity of their behaviors while being treated with this dietary supplement.

Description

Deliberate Self-Harm (DSH) among adolescents is a serious behavioral problem associated with significant morbidity and mortality, impaired functioning, reduced quality of life, and high rates of psychiatric hospitalizations. Rates of DSH among high-school adolescents range between 14% and 21%, highlighting the need for effective behavioral and pharmacological interventions . Because DSH has been closely linked to Borderline Personality Disorder (BPD), treatments that have been used successfully for BPD such as Dialectical Behavior Therapy (DBT) have been used to treat adolescents with DSH. 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. In addition to these high rates of DSH in adolescents, research is continuing to show that similar to adult patients; adolescent DSH is related to high levels of impulsivity.

Considerable advances in the understanding of the neurobiology of risk and reward and impulsivity have improved the general understanding of the neuropathology of a behavior such as DSH. Our previous neuroimaging research of DSH in BPD found that frontal white matter integrity was significantly impaired in these individuals. One conceptualization of DSH is that it represents an imbalance between a strong desire for the reward of DSH (i.e. an overactive ventral tegmental area [VTA]) and an inability to inhibit the drive (i.e. impaired inferior frontal cortex). If the frontal cortex is impaired due to inadequate white matter integrity as our earlier study demonstrated, then reducing the drive for DSH may be the most beneficial target for treatment. Glutamate is known to activate dopamine neurons in the VTA. Because such activation can increase dopamine release in mesocorticolimbic targets, this glutamate-dopamine interaction in the VTA may underlie the chronic reward-seeking that underlies DSH. In fact, dysregulated prefrontal cortex-nucleus accumbens synaptic glutamate transmission appears to underlie the unmanageable motivation to engage in DSH.

Because interactions of glutamate with the dopaminergic system within the VTA mediate reward, N-acetyl cysteine (NAC), a glutamate modulating agent, should attenuate the rewarding properties of DSH by interfering with DSH-induced stimulation of the mesolimbic dopaminergic pathway. NAC increases the activity of cysteine-glutamate antiporters in the nucleus accumbens and abolishes reward-seeking behavior. Behaviorally, NAC administration should lead to diminished urges to engage in DSH. Increased extracellular glutamate by NAC may correct the underlying pathophysiology and symptoms of this compulsive drive to self-injure. NAC has been extensively studied in a variety of medical problems (e.g., cocaine dependence, acetaminophen overdose, AIDS, gambling), and its lack of significant side effects may present a marked advantage over pharmacological agents.

There is a need to develop effective treatment options that are well tolerated, widely available, and do not have prohibitive costs. NAC is an amino acid, available in health food stores, cheaper than the cost of most insurance co-payments, and is easily tolerated. If effective, NAC could be a treatment option available to people throughout the country that do not currently have insurance but are suffering from DSH.

The population to be studied for this trial is 10 men and women, ages 16-21, who engage in deliberate self-harm behaviors at least twice a month. Study participants will be recruited from outpatient mental health clinics.

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.

All participants will be given the 1) Personality Assessment Inventory (adult) or adolescent form of the Personality Assessment Inventory administered at the Initial Intake as well as the 2) MINI or MINI Kid dependent on age. The Deliberate Self Harm Inventory will also be administered at initial intake. The 3) McClean Symptom Inventory-Borderline Personality Disorder, a 10 item self administered assessment for borderline personality disorder, the 4) Symptom Check-List-90-R, 5) Self Injury Assessment Scale, 6) Barrett Impulsivity Scale, and the 7) Columbia Suicide Severity Rating Scale will all be administered at this initial assessment for symptom severity.

Every two weeks the 1) Columbia Suicide Severity Rating Scale, the 2) Self Injury Assessment Scale, 3) Deliberate Self Harm Inventory Clinical Change Version will be utilized to assess the efficacy of current treatment.

At the end of the 8 week administration of NAC participants will complete the 1) Columbia Suicide Severity Rating Scale, 2) Deliberate Self Harm Inventory Clinical Change Version, 3) Self Injurious Assessment Scale, the 4) Barrett Impulsivity Scale to address overall efficacy of current level of intervention.

Study Design

Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Deliberate Self Harm

Intervention

N-Acetylcysteine

Location

University of Minnesota Dept. of Psychiatry Ambulatory Research Center
Minneapolis
Minnesota
United States
55454

Status

Not yet recruiting

Source

University of Minnesota - Clinical and Translational Science Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:25-0400

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