N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD
Condition: Borderline Personality Disorder; Self-Injurious Behavior
MeSH terms: Personality Disorders; Borderline Personality Disorder; Self-Injurious Behavior
Intervention: N-Acetylcysteine; placebo
Intervention description: 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks; placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Borderline Personality Disorder(BPD); Dialectical Behavioral Therapy (DBT); glutamate; N-Acetylcysteine; Borderline Personality Disorder with Self-Injurious Behavior

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.
    

Eligibility criteria:

        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