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| ID | Type | Description | Link |
|---|---|---|---|
| WV26504-4245 | Other Grant/Funding Number | WV26504-4245 |
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Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selegiline | Experimental | Transdermal Selegiline 12 mg patch Apply (1) patch daily |
|
| Placebo (for Selegiline) | Placebo Comparator | Transdermal Placebo patch Apply (1) patch daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selegiline | Drug | 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. |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J Markovitz, MD, PhD | Mood and Anxiety Research, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mood and Anxiety Research, Inc | Fresno | California | 93720 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36375174 | Derived | 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. |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D006261 | Headache |
| D008881 | Migraine Disorders |
| D043183 | Irritable Bowel Syndrome |
| D009450 | Neurodermatitis |
| D005356 | Fibromyalgia |
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012642 | Selegiline |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
| Placebo (for Selegiline) | Drug | Transdermal Placebo patch manufactured to mimic Transdermal Selegiline 12 mg. patch |
|
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 |
| Treatment Phase (1-12 weeks) |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |