A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of inositol for the treatment of compulsive hair pulling, also known as trichotillomania. Inositol is used for diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer, depression, schizophrenia, Alzheimer's disease, attention deficit-hyperactivity disorder (ADHD), autism, promoting hair growth, a skin disorder called psoriasis, and treating side effects of medical treatment with some medications, including lithium. The hypothesis to be tested is that Inositol will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of the disabling disorder that currently lacks a clearly effective treatment.
详细描述
Pathological hair-pulling, trichotillomania, has been defined as repetitive, intentionally performed pulling that causes noticeable hair loss and results in clinically significant distress or functional impairment (1). Trichotillomania appears relatively common with an estimated prevalence between 1-3% (2). Data on the pharmacological treatment of trichotillomania is limited to case reports and conflicting double-blind studies of serotonin reuptake inhibitors (3).
Inositol is used for diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer, depression, schizophrenia, Alzheimer's disease, attention deficit-hyperactivity disorder (ADHD), autism, promoting hair growth, a skin disorder called psoriasis, and treating side effects of medical treatment with some medications, including lithium. A small study (n=3) found that subject's showed improvement while taking Inositol in both trichotillomania and pathological skin picking (4). This suggests that Inositol might be effective in treating a large sample of subjects with trichotillomania and it also suggests that it may be effective for impulse control disorders in general. Inositol has also been shown to be effective in treating obsessive compulsive disorder and showed significantly lower scores on the Yale-Brown Obsessive Compulsive Scale (5). Both studies indicate the effectiveness of Inositol in treating impulsivity and compulsivity in subjects. There is no medication approved by the Food and Drug Administration for trichotillomania. Inositol represents a potentially safe and effective treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Age 18-65 years
- •Trichotillomania (TTM) as the primary psychiatric diagnosis
- •Women's participation required negative results on a beta-human chorionic gonadotropin pregnancy test and stable use of a medically accepted form of contraception.
- •Signed informed consent before entry into the study.
排除标准
- •Unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screening visit
- •Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- •A need for medication other than ecopipam with possible psychotropic effects
- •Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as determined by the Structured Clinical Interview for DSM-IV
- •Current (past 12-months) DSM-IV substance abuse or dependence
- •Positive urine drug screen at screening
- •Initiation of cognitive behavior therapy within 3 months prior to study baseline
- •Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS
- •Any suicidality based on clinical interview
- •History of head injury or neurological disorder (such as seizures)
- •Any history of psychiatric hospitalization in the past year
- •Any history of a suicide attempt
研究组 & 干预措施
Placebo
Matched dosage of inositol daily.
干预措施: Placebo (Drug)
Inositol
Powder form, 2g TID up to 6g TID
干预措施: Inositol (Drug)
结局指标
主要结局
The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)
时间窗: Once every two weeks for the 10 weeks of the study
The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the NIMH-TSS for the duration of the 10 weeks, but only baseline and final values will be used for general final outcome assessment. The scale itself asses severity of hair pulling.
次要结局
- The Massachusetts General Hospital (MGH) Hairpulling Scale(Once every two weeks for the 10 weeks of the study)
