Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
研究概览
简要总结
Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with trichotillomania can experience significant impairment due to peer teasing, avoidance of activities (such as swimming and socializing), difficulty concentrating on school work and medical complications due to pulling behaviors. Despite the fact that trichotillomania has a childhood onset, no randomized, controlled trials have been completed in childhood trichotillomania.
Research in adults with trichotillomania has demonstrated that most commonly currently prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake inhibitors) is ineffective in treating this condition. By contrast, randomized controlled trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral treatments such as Habit Reversal Therapy.
The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign side-effect profile.
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
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 8-17 years.
- •Primary DSM-IV diagnosis of trichotillomania or chronic hair pulling.
- •Duration of trichotillomania greater than 6 months.
排除标准
- •Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (IQ<70).
- •Recent change (less than 4 weeks) in medications that have potential effects on TTM severity (such as SSRIs, CMI, naltrexone, lithium, psychostimulants, anxiolytics, or antipsychotics). Medication change is defined to include either dose changes or medication discontinuation.
- •Asthma requiring medication use within the last 6 months.
- •Known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation
- •Current use (within last week) of psychostimulant medications.
- •Positive pregnancy test or drug screening test
研究组 & 干预措施
N-acetylcysteine (NAC)
Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
干预措施: N-Acetylcysteine (Drug)
Placebo
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
干预措施: Placebo (Drug)
结局指标
主要结局
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
时间窗: Week 12
The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.
次要结局
- Trichotillomania Scale for Children - Child Version(Week 12)
- Multidimensional Anxiety Scale for Children (MASC)(Week 12)
- Trichotillomania Scale for Children - Parent Version(Week 12)
- The Milwaukee Inventory for Styles of Trichotillomania-Child Version(Week 12)
- National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS)(Week 12)
- Children's Depression Inventory(Week 12)