Borderline Personality Disorder Clinical Trial
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 Personality Disorder
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.
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. ;
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