Once Weekly Semaglutide Treatment of Trichotillomania: An Open-Label Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- NIMH Trichotillomania Severity Scale
研究概览
简要总结
This research study is testing the effectiveness and safety of semaglutide (Wegovy) in people with trichotillomania, also known as hair-pulling disorder.
详细描述
The goal of the proposed study is to evaluate the efficacy and safety of semaglutide in individuals with trichotillomania. The hypothesis to be tested is that semaglutide will reduce urges to pull hair and pulling behavior and will be well tolerated in participants with trichotillomania. The proposed study will provide needed pilot data on the treatment of a disabling disorder that currently lacks available options for pharmacological treatment.
The investigators will conduct an open-label pharmacotherapy trial in 10 individuals with trichotillomania. Participants with trichotillomania will be started and continued on medication during an 8-week treatment phase. The study will be the first to use a once weekly Glucagon-like peptide 1 (GLP-1) receptor agonist pharmacological intervention to target urges in trichotillomania and thereby has the potential to set a new standard of care for a range of compulsive behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 18-75;
- •Diagnosis of current trichotillomania based on DSM-5 criteria and confirmed using the clinician-administered MIDI (13);
- •Hair pulling daily with urges to pull as the trigger in >50% of the episodes of pulling;
- •Women of childbearing age are required to have a negative result on a beta-human chorionic gonadotropin pregnancy test;
- •Women of childbearing potential utilizing a medically accepted form of contraception defined as double barrier, oral contraceptive, injectable contraceptive, implantable contraceptive devices, and abstinence
排除标准
- •Infrequent pulling (i.e. less than daily) or automatic pulling (i.e. no urges to pull);
- •Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen as determined by the investigator;
- •History of seizures;
- •Myocardial infarction within 6 months;
- •Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- •A need for medication other than semaglutide with possible psychotropic effects or unfavorable interactions as determined by the investigator;
- •Clinically significant suicidality (defined by the Columbia Suicide-Severity Rating Scale);
- •Lifetime history of bipolar disorder type I or II, schizophrenia, or any psychotic disorder;
- •Current skin picking disorder;
- •Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
- •Initiation of psychotropic medications within 3 months prior to study baseline (stable doses will be allowed);
- •Previous treatment with semaglutide;
- •Use of any weight loss medications;
- •Body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) less than 23;
- •Past-year substance use disorder other than tobacco use disorder or mild cannabis use disorder;
- •Recent (30-day) use of illicit drugs except cannabis;
- •History of diabetes, and current medical or neurological illness precluding participation based on physician judgment;
- •Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B;
- •History of pancreatitis.
研究组 & 干预措施
Semaglutide (Wegovy)
Participants will receive semaglutide (Wegovy) weekly for 8 weeks.
干预措施: Semaglutide (Drug)
结局指标
主要结局
NIMH Trichotillomania Severity Scale
时间窗: From screening to 1 week after last dose of study drug
Clinician-rated scale assessing trichotillomania symptom severity over the past week that will be administered at all visits. Total scores range from 0-20. Higher scores indicate greater severity.
次要结局
- Clinical Global Impression-Improvement and Severity Scales(From screening to 1 week after last dose of study drug)
- Massachusetts General Hospital Hair Pulling Scale(From screening to 1 week after last dose of study drug)