Clinical trial NCT01912391: Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Borderline Personality Disorder
Keywords: Depression
Anxiety
Headaches
Migraines
Irritable Bowel Syndrome IBS
Neurodermatitis
Fibromyalgia
Premenstrual Syndrome PMS
Temporomandibular Joint Dysfunction TMJ
Lead sponsor: Mood and Anxiety Research, Inc
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale
timeFrame: Weeks 1-12
Secondary outcomes:
measure: Secondary Efficacy Measurement: Change in Hamilton Depression Inventory 17 Questions (HAM-D)
timeFrame: Weeks 1 - 12
measure: Clinical Global Impression of Change- Clinician (CGIc)
timeFrame: Weeks 3-12
measure: Clinical Global Impression Change- Patient (CGIp)
timeFrame: Weeks 3 -12
measure: Sheehan Disability Scale (SDS)
timeFrame: Weeks 1, 4, 12
Other outcomes:
measure: 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
timeFrame: Treatment Phase (1-12 weeks)
Locations:
city: Fresno
country: United States
facility: Mood and Anxiety Research, Inc
state: California
Study officials:
affiliation: Mood and Anxiety Research, Inc
name: Paul J Markovitz, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.