A Double-Blind, Placebo Controlled Study of Aripiprazole in Body Focused Repetitive Behaviors
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- NIMH Symptom Severity Scale (for TTM or Skin Picking)
研究概览
简要总结
This study is 6 weeks long and involves subjects taking aripiprazole or placebo. If they are randomly assigned to the aripiprazole arm and are eligible to participate in the study, they will begin by taking 5mg once daily of aripiprazole for two weeks, then 10mg once daily for the remaining three weeks. Efficacy and safety measures will be performed at each visit. Participants will be randomized to receive either aripiprazole or placebo on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.
详细描述
The goal of the proposed study is to evaluate the efficacy and safety of aripiprazole in 100 subjects with DSM-5 trichotillomania (TTM) or skin picking disorder (SPD).
The hypothesis to be tested is that aripiprazole will be effective and well tolerated in patients with BFRBs (trichotillomania or skin picking disorder) compared to placebo. The proposed study will provide needed data on the treatment of disabling disorders that currently lack a clearly effective treatment.
This will be one of few studies assessing the use of pharmacotherapy for the treatment of TTM and SPD in adults. Assessing the efficacy and safety of aripiprazole will help inform clinicians about additional treatment options for adults suffering from this disorder.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age ≥18 years
- •current DSM-5 trichotillomania or skin picking disorder; and
- •Ability to understand and sign the consent form.
排除标准
- •Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- •Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- •Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
- •Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder
- •Illegal substance use based on urine toxicology screening
- •Stable dose of medications for at least the past 3 months
- •Previous treatment with aripiprazole
- •Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
研究组 & 干预措施
Placebo
5mg once daily of placebo for three weeks, then 10mg once daily for the remaining three weeks.
干预措施: Placebo (Drug)
Aripiprazole
5mg once daily of aripiprazole for three weeks, then 10mg once daily for the remaining three weeks.
干预措施: Aripiprazole (Drug)
结局指标
主要结局
NIMH Symptom Severity Scale (for TTM or Skin Picking)
时间窗: The primary efficacy end points will be the change in these measures from baseline to week 6.
The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score. The entire study lasts 6 weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to after 6 weeks will be assessed. The scale itself assesses severity of trichotillomania symptoms. The NIMH-TSS score ranges from 0 to 20, with 0 being no symptoms and 20 being the most severe.
次要结局
- Hamilton Anxiety Rating Scale(6 weeks)
- Clinical Global Impressions-Improvement Scale (CGI-I)(6 weeks)
- Massachusetts General Hospital Hairpulling (Skinpicking) Scale(6 weeks)
- Quality of Life Inventory(6 weeks)
- Sheehan Disability Scale(6 weeks)
- Hamilton Depression Rating Scale(6 weeks)
- Tridimensional Personality Questionnaire(6 weeks)
- Cambridge Caffeine Use Survey(6 weeks)
- Skin Picking Symptom Assessment Scale(6 weeks)
- Cambridge-Chicago Trait Scale(6 weeks)