A Phase III Randomized Double-blind, 12 Week, Placebo Controlled Trial of Transdermal Selegiline in Borderline Personality Disorder (BPD) to Evaluate Efficacy and Safety
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale
研究概览
简要总结
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Selegiline
Transdermal Selegiline 12 mg patch Apply (1) patch daily
干预措施: Selegiline (Drug)
Placebo (for Selegiline)
Transdermal Placebo patch Apply (1) patch daily
干预措施: Placebo (for Selegiline) (Drug)
结局指标
主要结局
Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale
时间窗: 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.
次要结局
- Clinical Global Impression Change- Patient (CGIp)(Weeks 3 -12)
- Clinical Global Impression of Change- Clinician (CGIc)(Weeks 3-12)
- Secondary Efficacy Measurement: Change in Hamilton Depression Inventory 17 Questions (HAM-D)(Weeks 1 - 12)
- Sheehan Disability Scale (SDS)(Weeks 1, 4, 12)