Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.
Borderline Personality Disorder
Drug: Placebo (for Selegiline)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]The study subject will complete the SCL 90-R questionnaire at each visit on arrival at the office prior to meeting with the research staff. This will serve as the primary efficacy measure of outcome for the study. This instrument has been utilized in clinical trials since the early 1960s, and has a good ability to measure overall levels of psychological and physical functioning in this patient group.
- Secondary Efficacy Measurement: Change in Hamilton Depression Inventory 17 Questions (HAM-D) [ Time Frame: Weeks 1 - 12 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Patient will assess any improvement in their overall functioning in their work / school, social and daily life at 3 time points
- Clinical and Laboratory Measurements for Safety: Change in Columbia Suicide Severity Rating Scale (CSSRS); Adverse Events; Vitals Signs; Body Weight; Laboratory Values; Blood Pressure; Study Drug Compliance; Concomitant Medication Compliance [ Time Frame: Treatment Phase (1-12 weeks) ] [ Designated as safety issue: Yes ]Study subjects will be monitored for safety throughout the study beginning at the Screening Visit (V1). At each visit, subjects will have various clinical, laboratory and safety measurements conducted. Results will be assessed by the clinical team and will be monitored, at each visit, until the term of their participation. A 2 week, post-study, follow-up will be conducted by the study staff.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Transdermal Selegiline 12 mg patch Apply (1) patch daily
The Study Drug known as either selegiline 12 mg patch or matching placebo patch will be administered daily beginning at Visit 2 for the duration of 12 weeks.
Other Name: Emsam
Placebo Comparator: Placebo (for Selegiline)
Transdermal Placebo patch Apply (1) patch daily
Drug: Placebo (for Selegiline)
Transdermal Placebo patch manufactured to mimic Transdermal Selegiline 12 mg. patch
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.
|Contact: Paul J Markovitz, MD, PhD||559-353-3927 ext firstname.lastname@example.org|
|Contact: Paula L Thompson, BA||559-353-3927 ext email@example.com|
|United States, California|
|Mood and Anxiety Research, Inc||Recruiting|
|Fresno, California, United States, 93720|
|Contact: Paula L Thompson, BA 559-353-3927 ext 3 firstname.lastname@example.org|
|Principal Investigator: Paul J Markovitz, MD, PhD|
|Study Director:||Paul J Markovitz, MD, PhD||Mood and Anxiety Research, Inc|