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

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ClinicalTrials.gov Identifier: NCT00539188
Recruitment Status : Terminated (Study terminated due to poor subject compliance.)
First Posted : October 4, 2007
Results First Posted : March 6, 2013
Last Update Posted : April 1, 2013
Sponsor:
Information provided by (Responsible Party):
Christopher Pittenger, Yale University

Tracking Information
First Submitted Date  ICMJE October 2, 2007
First Posted Date  ICMJE October 4, 2007
Results First Submitted Date  ICMJE December 21, 2012
Results First Posted Date  ICMJE March 6, 2013
Last Update Posted Date April 1, 2013
Study Start Date  ICMJE September 2007
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
  • 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 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2007)
  • Self-Harm Inventory (SHI) [ Time Frame: 6 weeks ]
  • Visual analog scale for subjective urges to engage in SIB [ Time Frame: 6 weeks ]
Change History Complete list of historical versions of study NCT00539188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
  • 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 Measures  ICMJE
 (submitted: October 3, 2007)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD
Official Title  ICMJE A Double-Blind, Placebo-controlled Pilot Study of NAC Addition to Dialectical Behavioral Therapy for the Treatment of Self-Injurious Behavior Associated With Borderline Personality Disorder
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 effect similar to riluzole in a case of treatment-refractory obsessive-compulsive disorder.

This study will be a double-blind, randomized, and placebo-controlled evaluation of N-Acetylcysteine as an adjunct to DBT in the treatment of SIB associated with BPD. Subjects participating in this study will be recruited exclusively from the Dialectical Behavioral Therapy program of the Yale-New Haven Hospital, in order to maximize homogeneity of the psychotherapeutic care received during their participation.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Borderline Personality Disorder
  • Self-Injurious Behavior
Intervention  ICMJE
  • Drug: N-Acetylcysteine
    3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks
    Other Name: NAC
  • Drug: placebo
    placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
Study Arms  ICMJE
  • Experimental: N-Acetylcysteine
    Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
    Intervention: Drug: N-Acetylcysteine
  • Placebo Comparator: placebo
    Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 29, 2013)
6
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2007)
40
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Borderline Personality Disorder, as assessed by SCID-II
  • A score of 10 or greater on the Self Harm Inventory (SHI) at time of evaluation
  • Ability to give informed consent
  • agreement to engage in a reliable form of birth control (women only)

Exclusion Criteria:

  • primary diagnosis of a psychotic disorder
  • active substance abuse or dependence
  • unstable medical condition
  • History of intolerance/allergic reaction to N-Acetylcysteine
  • pregnancy, breastfeeding, or intent to become pregnant during study
  • Inability to understand English
  • Cognitive Impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00539188
Other Study ID Numbers  ICMJE YOCD-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher Pittenger, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher J Pittenger, MD,PhD Yale University
PRS Account Yale University
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP