Acetaminophen and Social Pain in Borderline Personality Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change from baseline in symptom reports on the PAI-BOR at week 6
研究概览
简要总结
Recent research has identified heightened sensitivity to social rejection as a core feature of BPD. Rejection sensitivity can trigger the aggressive, impulsive, and self-injurious behaviors characteristic of the disorder.
Therefore targeting therapy towards the reduction of rejection sensitivity may improve the low rates of effectiveness of current pharmacological and behavioral therapies. Therefore, this proposal tests a theoretically-based pharmacological approach that specifically targets the heightened sensitivity to rejection experienced by BPD patients.
In prior research with normal controls, it was shown that chronic treatment with the physical pain-killer acetaminophen (e.g. Tylenol) reduced both neural responses to social rejection (using fMRI) as well as self-reported feelings of rejection in a daily diary study.
It is the aim of this research project to determine if the over-the-counter analgesic, acetaminophen (active ingredient in Tylenol), can reduce symptoms and behaviors in BPD patients. The goal of this proposal is to use an open-label design to determine if acetaminophen improves symptoms in BPD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of borderline personality disorder
- •18 years or older
- •if on psychiatric medication, must be on a stable dose
- •able to swallow tablets
排除标准
- •current, primary substance abuse, particularly alcoholism
- •current eating disorder
- •history or current psychotic disorder
- •suicidal ideation or behavior requiring imminent inpatient treatment
- •pregnancy
- •Participants whose medication has not been stable for more than 4 weeks
- •Impaired liver function (> 1.25x the upper limit of the reference range)
- •Conditions that can affect immune system functioning.
研究组 & 干预措施
Acetaminophen 1000mg
Acetaminophen 1000mg capsule orally three times a day
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Change from baseline in symptom reports on the PAI-BOR at week 6
时间窗: Baseline, Week 6
Symptom reports on the PAI-BOR.
Change from baseline in symptom severity on the Zanarini Rating Scale for Borderline Personality Disorder
时间窗: Baseline, Week 6
Zanarini Rating Scale for Borderline Personality Disorder
次要结局
- Symptom Reports(Baseline, weeks, 1,2,3,4,5,6 and 8.)
- Daily Diary(Daily for week 0,1,2, and 3)
研究者
Baldwin Way
Assistant Professor
Ohio State University