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

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

Detailed Description
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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.

Official Title
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A Phase III Randomized Double-blind, 12 Week, Placebo Controlled Trial of Transdermal Selegiline in Borderline Personality Disorder (BPD) to Evaluate Efficacy and Safety

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Drug: Selegiline
* Drug: Placebo (for Selegiline)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selegiline<br>Transdermal Selegiline 12 mg patch Apply (1) patch daily | Drug: Selegiline<br>* 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.<br>* Other names: Emsam;|
| Placebo Comparator: Placebo (for Selegiline)<br>Transdermal Placebo patch Apply (1) patch daily | Drug: Placebo (for Selegiline)<br>* Transdermal Placebo patch manufactured to mimic Transdermal Selegiline 12 mg. patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Weeks 1-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Weeks 1 - 12 | 
| 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). | Weeks 3-12 | 
| 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). | Weeks 3 -12 | 
| 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 | Weeks 1, 4, 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Anxiety, Headaches, Migraines, Irritable Bowel Syndrome IBS, Neurodermatitis, Fibromyalgia, Premenstrual Syndrome PMS, Temporomandibular Joint Dysfunction TMJ