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Trial record 33 of 610 for:    Personality Disorders

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01912391
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : October 8, 2015
Information provided by (Responsible Party):
Mood and Anxiety Research, Inc

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

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: Selegiline Drug: Placebo (for Selegiline) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Selegiline

Arm Intervention/treatment
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

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

  2. 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).

  3. 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).

  4. 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

Other Outcome Measures:
  1. 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) ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01912391

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United States, California
Mood and Anxiety Research, Inc
Fresno, California, United States, 93720
Sponsors and Collaborators
Mood and Anxiety Research, Inc
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Study Director: Paul J Markovitz, MD, PhD Mood and Anxiety Research, Inc

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Responsible Party: Mood and Anxiety Research, Inc Identifier: NCT01912391     History of Changes
Other Study ID Numbers: PJM-01
WV26504-4245 ( Other Grant/Funding Number: WV26504-4245 )
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015

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

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