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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Mood and Anxiety Research, Inc
Sponsor:
Information provided by (Responsible Party):
Mood and Anxiety Research, Inc
ClinicalTrials.gov Identifier:
NCT01912391
First received: July 16, 2013
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Borderline Personality Disorder
Drug: Selegiline
Drug: Placebo (for Selegiline)
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Mood and Anxiety Research, Inc:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 38
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)
Arms Assigned Interventions
Experimental: Selegiline
Transdermal Selegiline 12 mg patch Apply (1) patch daily
Drug: Selegiline
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject has primary diagnosis of Borderline Personality Disorder(BPD).
  • Subject has Symptomatology of BPD for at least 1 year.
  • Subject understands the study procedures and voluntarily agree to participate.
  • Subject is able to read, understand and complete questionnaires.
  • Subject agrees to use (2)acceptable forms of contraception throughout the study.
  • Patient must have a screening SCL 90-R score of > 120 (range 0-360).

Exclusion Criteria:

  • Subject is not pregnant or breast feeding.
  • Subject is unlikely to adhere to the study procedures and restrictions.
  • Patient has failed treatment due to lack of efficacy of monoamine oxidase inhibitor(MAOI) medication.
  • Patient anticipates need for surgery during the study.
  • Patient has another predominant personality disorder other than BPD.
  • Subject has an active history of substance abuse or dependence, e.g.,Positive Drug screen
  • Subject has other health issues which could interfere with study interpretation.
  • Subject reports recent suicide attempts or homicide attempts in the past 3 months.
  • Subject must be substance abuse or dependence clean for (1) year.
  • Subject has a history of a primary malignancy < 5 yrs.
  • Subject has a medical condition(s)that are excluded, per Protocol, or are unstable.
  • Subject has abnormal screening laboratory values, per Protocol, or other clinically significant, unexplained laboratory abnormality.
  • Subject is currently participating or has participated in a study within 30 days.
  • Patient has donated blood products or has had phlebotomy of > 300 ml within 8 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912391

Contacts
Contact: Paul J Markovitz, MD, PhD 559-353-3927 ext 1 pjmforbpd@aol.com
Contact: Paula L Thompson, BA 559-353-3927 ext 3 crc.paula@gmail.com

Locations
United States, California
Mood and Anxiety Research, Inc Recruiting
Fresno, California, United States, 93720
Contact: Paula L Thompson, BA    559-353-3927 ext 3    crc.paula@gmail.com   
Principal Investigator: Paul J Markovitz, MD, PhD         
Sponsors and Collaborators
Mood and Anxiety Research, Inc
Investigators
Study Director: Paul J Markovitz, MD, PhD Mood and Anxiety Research, Inc
  More Information

No publications provided

Responsible Party: Mood and Anxiety Research, Inc
ClinicalTrials.gov Identifier: NCT01912391     History of Changes
Other Study ID Numbers: PJM-01, WV26504-4245
Study First Received: July 16, 2013
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mood and Anxiety Research, Inc:
Depression
Anxiety
Headaches
Migraines
Irritable Bowel Syndrome IBS
Neurodermatitis
Fibromyalgia
Premenstrual Syndrome PMS
Temporomandibular Joint Dysfunction TMJ

Additional relevant MeSH terms:
Borderline Personality Disorder
Disease
Personality Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014