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

Primary Purpose

Borderline Personality Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Selegiline

Placebo (for Selegiline)

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Depression, Anxiety, Headaches, Migraines, Irritable Bowel Syndrome IBS, Neurodermatitis, Fibromyalgia, Premenstrual Syndrome PMS, Temporomandibular Joint Dysfunction TMJ

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mood and Anxiety Research, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Selegiline

Placebo (for Selegiline)

Arm Description

Transdermal Selegiline 12 mg patch Apply (1) patch daily

Transdermal Placebo patch Apply (1) patch daily

Outcomes

Primary Outcome Measures

Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale

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)

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)

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)

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)

Patient will assess any improvement in their overall functioning in their work / school, social and daily life at 3 time points

Full Information

NCT ID

NCT01912391

First Posted

July 16, 2013

Last Updated

October 6, 2015

Sponsor

Mood and Anxiety Research, Inc

1. Study Identification

Unique Protocol Identification Number

NCT01912391

Brief Title

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

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mood and Anxiety Research, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Borderline Personality Disorder

Keywords

Depression, Anxiety, Headaches, Migraines, Irritable Bowel Syndrome IBS, Neurodermatitis, Fibromyalgia, Premenstrual Syndrome PMS, Temporomandibular Joint Dysfunction TMJ

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Selegiline

Arm Type

Experimental

Arm Description

Transdermal Selegiline 12 mg patch Apply (1) patch daily

Arm Title

Placebo (for Selegiline)

Arm Type

Placebo Comparator

Arm Description

Transdermal Placebo patch Apply (1) patch daily

Intervention Type

Drug

Intervention Name(s)

Selegiline

Other Intervention Name(s)

Emsam

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo (for Selegiline)

Intervention Description

Transdermal Placebo patch manufactured to mimic Transdermal Selegiline 12 mg. patch

Primary Outcome Measure Information:

Title

Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale

Description

Time Frame

Weeks 1-12

Secondary Outcome Measure Information:

Title

Secondary Efficacy Measurement: Change in Hamilton Depression Inventory 17 Questions (HAM-D)

Description

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.

Time Frame

Weeks 1 - 12

Title

Clinical Global Impression of Change- Clinician (CGIc)

Description

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).

Time Frame

Weeks 3-12

Title

Clinical Global Impression Change- Patient (CGIp)

Description

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).

Time Frame

Weeks 3 -12

Title

Sheehan Disability Scale (SDS)

Description

Patient will assess any improvement in their overall functioning in their work / school, social and daily life at 3 time points

Time Frame

Weeks 1, 4, 12

Other Pre-specified Outcome Measures:

Title

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

Description

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.

Time Frame

Treatment Phase (1-12 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul J Markovitz, MD, PhD

Organizational Affiliation

Mood and Anxiety Research, Inc

Official's Role

Study Director

Facility Information:

Facility Name

Mood and Anxiety Research, Inc

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

36375174

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.

Results Reference

derived

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

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