Clinical Trial: Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.

Detailed Summary:

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.

Current Primary Outcome: Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale [ Time Frame: Weeks 1-12 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Secondary Efficacy Measurement: Change in Hamilton Depression Inventory 17 Questions (HAM-D) [ Time Frame: Weeks 1 - 12 ]
  Clinician will administer the HAM-D scale to subject at each visit to assess any changes in their overall symptoms, functioning social and daily life.
• Clinical Global Impression of Change- Clinician (CGIc) [ Time Frame: Weeks 3-12 ]
  Clinician will assess any improvement in their overall symptoms, functioning social and daily life beginning at week 3(Visit 3)through week 12 (Visit 6).
• Clinical Global Impression Change- Patient (CGIp) [ Time Frame: Weeks 3 -12 ]
  Patient will assess any improvement in their overall symptoms, functioning social and daily life beginning at week 3(Visit 3)through week 12 (Visit 6).
• Sheehan Disability Scale (SDS) [ Time Frame: Weeks 1, 4, 12 ]
  Patient will assess any improvement in their overall functioning in their work / school, social and daily life at 3 time points

Original Secondary Outcome: Same as current

Information By: Mood and Anxiety Research, Inc

Dates:
Date Received: July 16, 2013
Date Started: October 2012
Date Completion:
Last Updated: October 6, 2015
Last Verified: October 2015