Clinical Trial: N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Double-Blind, Placebo-controlled Pilot Study of NAC Addition to Dialectical Behavioral Therapy for the Treatment of Self-Injurious Behavior Associated With Borderline Pe

Brief Summary:

Self-Injurious Behavior (SIB) is a dangerous and common symptom in Borderline Personality Disorder (BPD) patients. Approximately 70% of patients with BPD engage in SIB at some point, compared to 17.5% of patients with other personality disorders. While SIB may prompt unnecessary psychiatric hospitalizations, it may also cause potential underestimation of the lethality of suicidal behavior, thus creating a major and confusing challenge in the practice of clinical psychiatry.

Dialectical Behavioral Therapy (DBT) is a collection of therapeutic techniques focused on emotional regulation, impulse control, and improving safety in patients with BPD and others with marked self-destructive behavioral tendencies. Though DBT has marked ability to reduce BPD symptomatology, including SIB, improvement in SIB is limited and dependent on extensive therapy and time.

Furthermore, the literature on the pharmacological treatment of SIB associated with BPD is scarce. Animal studies suggest that SIB may be associated with an imbalance between dopamine and glutamate in the brain. Anti-seizure medications that modulate glutamate transmission, such as lamotrigine and topiramate, have been suggested to be effective in the treatment of SIB in humans.

Preliminary evidence suggests that antiglutamatergic medications may decrease SIB in patients with BPD. Early studies have focused on the antiglutamatergic drug riluzole. More recently, we have become interested in the amino acid N-acetylcysteine (NAC), which is used clinically for its antioxidant properties and is widely available as a nutritional supplement. Recent animal studies have suggested that NAC can modulate glutamate in the central nervous system in a way very similar to that proposed for riluzole, and indeed we have observed NAC to have an e

Detailed Summary: Investigators have withdrawn study due to poor subject compliance. After 3 consecutive participants were either unable to complete all 6 weeks of the study or dropped out of the DBT program, a decision was reached to discontinue recruitment and study was terminated.
Sponsor: Yale University

Current Primary Outcome:

  • Self-Harm Inventory (SHI) Score at 6 Weeks [ Time Frame: 6 weeks ]

    The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever "intentionally, or on purpose" tried to harm themselves. The inventory contains 22 questions and a 23rd marked "other" that allows the individual to indicate a self-harm behavior not previously mentioned.

    The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.

    In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported.

  • Self-Harm Inventory (SHI) Score at Baseline [ Time Frame: Baseline ]

    The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever "intentionally, or on purpose" tried to harm themselves. The inventory contains 22 questions and a 23rd marked "other" that allows the individual to indicate a self-harm behavior not previously mentioned.

    The scoring of this instrument is determined by counting the number of endorsed self-harm be

    Original Primary Outcome:

    • Self-Harm Inventory (SHI) [ Time Frame: 6 weeks ]
    • Visual analog scale for subjective urges to engage in SIB [ Time Frame: 6 weeks ]


    Current Secondary Outcome:

    • Hamilton Depression Rating Scale (HAM-D) at 6 Weeks [ Time Frame: 6 weeks ]

      The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52.

      HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression

      ≥23 = Very Severe Depression

      In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression.

    • Hamilton Depression Rating Scale (HAM-D) at Baseline [ Time Frame: Baseline ]

      The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52.

      HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression

      ≥23 = Very Severe Depression

      In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression.



    Original Secondary Outcome:

    • Structured Clinical Interview for DSM-IV Axis I and II Disorders (SCID) [ Time Frame: 1 week ]
    • CGI Severity of Illness item [ Time Frame: 6 weeks ]
    • Hamilton Anxiety (HAM-A) [ Time Frame: 6 weeks ]
    • Dissociative Experiences Scale (DES) [ Time Frame: 6 weeks ]
    • Functional Assessment of Self Mutilation (FASM) [ Time Frame: 6 weeks ]
    • State-Trait Anger Expression Inventory (STAXI) [ Time Frame: 6 weeks ]
    • Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 6 weeks ]
    • Five-Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 6 weeks ]
    • 16-Item Acceptance and Action Questionnaire (AAQ) [ Time Frame: 6 weeks ]


    Information By: Yale University

    Dates:
    Date Received: October 2, 2007
    Date Started: September 2007
    Date Completion:
    Last Updated: March 25, 2013
    Last Verified: March 2013