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Study of a Medication in Borderline Personality Disorder

 

Susan L. McElroy, MD

Lindner Center of HOPE, Chief Research Officer and Consultant to Eating Disorders Team

Borderline personality disorder (BPD) is a mental disorder consisting of a pervasive pattern of instability in regulation of emotions, impulses, interpersonal relationships, and self-image. Symptoms of BPD include frequent mood changes and excessive anger; feelings of worthlessness, insecurity, loneliness, and emptiness; periodic distortion of reality; and unhealthy social relationships.  Individuals with BPD are prone to self-harm (including suicidal ideation and behavior, self-cutting, and completed suicide), aggression, problematic alcohol and drug use, and other dangerous behaviors. The cause of BPD is unknown but thought to involve both genetic and environmental factors. Diagnosis is made clinically based on symptoms.

BPD is very common. It occurs in up to 5.9% of the general population and represents 15% to 29% of patients in psychiatric clinics and hospitals. Because the personality of children and adolescents is developing, the features of BPD do not become recognizable until late adolescence or early adulthood. Once the disorder appears, its course is often chronic. Though BPD is more common in women, a substantial number of men have the disorder as well.  There is a high comorbidity of BPD with other psychiatric disorders (approximately 85%), including anxiety disorders, mood disorders, impulse-control disorders, substance-use disorder, and eating disorders.

The present standard of treatment of BPD is psychotherapy, especially a form of psychotherapy called dialectical behavior therapy, to help individuals with tolerating distress and managing mood changes, impulses to self-harm, and relationships.  Most patients with BPD also receive psychiatric medication to target mood instability and excessive anger, impulsive and self-harming behavior, and cognitive and perceptual distortions. Small studies suggest medications that affect the dopamine and serotonin systems, particularly atypical (or second generation) antipsychotics (such as aripiprazole, quetiapine, and olanzapine), can be helpful for these symptoms. However, no medication has been approved by the United States Food and Drug Administration for the treatment of individuals with BPD.

The Research Institute at the Lindner Center of HOPE is participating in two important studies of one such medication, brexpiprazole, for treating BPD (clintrials.gov identifier NCT04100096 and NCT04186403) and is actively seeking individuals with BPD for participation. The first study is a 12-week, double-blind, placebo-controlled trial to evaluate the efficacy and safety of brexpiprazole for the treatment of individuals diagnosed with BPD. The second study is a six-month open-label trial of brexpiprazole in individuals who have completed the first study. (Open-label means all participants will receive brexpiprazole; no one receives placebo).

Otsuka Pharmaceutical Development and Commercialization, Inc., the manufacturers of brexpiprazole, is sponsoring the studies. Of note, brexpiprazole already has approval from the United States Food and Drug Administration for the treatment of schizophrenia and major depressive disorder (the later in combination with an antidepressant).

Please see the following links to get more information about the study:

https://clinicaltrials.gov/ct2/show/NCT04100096?term=Rexulti&cond=Borderline+Personality+Disorder&draw=1&rank=2

https://clinicaltrials.gov/ct2/show/NCT04186403?term=rexulti&draw=1&rank=8

https://lindnercenterofhope.org/research/

You may also contact Morgan Pond at morgan.pond@lindnercenter.org  or (513) 536-0704.

For further information on BPD:

https://www.nimh.nih.gov/health/topics/borderline-personality-disorder/index.shtml