Borderline Personality Disorder Clinical Trial
Official title:
A Phase III Randomized Double-blind, 12 Week, Placebo Controlled Trial of Transdermal Selegiline in Borderline Personality Disorder (BPD) to Evaluate Efficacy and Safety
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.
Borderline Personality Disorder (BPD) is a chronic disorder occurring in 2-3% of the
population. BPD is accompanied by high levels of co-existing psychiatric and physical
disorders. One key predictor is persistent and recurring major depressive disorder.
Since BPD is most closely linked with mood disorders and depression in particular, the use
of antidepressant medications to treat the disorder is logical. However, to date, there are
no FDA approved treatments for BPD. The American Psychiatric Association's Treatment
Guidelines for Borderline Personality Disorder recommend antidepressants as a primary
treatment of the disorder.
Earlier trials using antidepressants that increase certain brain chemicals, such as,
serotonin and noradrenalin have shown efficacy in controlling the mood swings of the illness
for many people. These studies also document efficacy in controlling physical disorders,
including headaches, migraines, irritable bowel, neurodermatitis (skin rash), fibromyalgia,
premenstrual syndrome, and tempomandibular joint dysfunction (TMJ).
group of antidepressants known as monoamine oxidase inhibitors (MAOIs) have also been shown
to be effective in BPD patients. The oral form of these medications was accompanied by
dietary restrictions, potential drug interactions, blood pressure changes and weight gain.
Selegiline, a MAOI antidepressant, was put into a skin patch delivery system (transdermal)
that reduced the side-effect profile. Trials without placebo control showed many individuals
with BPD benefit from the selegiline skin patch. This trial will look at individuals on the
selegiline and placebo to make sure the selegiline is or is not effective in treating BPD.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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