Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Clinical Global Impressions Scale change scores (week 2 versus 22)
研究概览
简要总结
The purpose of this study is to assess the extent of symptom remission in patients with trichotillomania following treatment with sertraline and/or behavior therapy.
详细描述
The purpose of this study is to assess the extent of symptom remission in patients with trichotillomania following treatment with sertraline and/or behavior therapy.
Following entry into the study, subjects will undergo a washout period if they are currently taking a psychotropic medication (two weeks for psychotropic medications except for fluoxetine, which requires a four-week washout). Subjects will then be given a single-blind placebo for two weeks and assessed for symptom consistency.
Subjects will take sertraline or placebo in a double-blind design. Subjects will be assessed with the Hamilton Rating Scale for Depression (HAM-D-17), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Clinical Global Impressions Scale (CGI), Hair Pulling Scale (HPS), Trichotillomania (TTM) Impact Scale, Psychiatric Institute Trichotillomania Scale (PITS), National Institute of Mental Health (NIMH) Scale, and Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) at the start of the washout period and at the end of week two in order to be randomized into the study. Subject randomization to a treatment arm will be based on the random table and in equal proportions.
Subject change scores will be assessed for the above scales, and change scores for the four different treatment groups will be assessed.
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
- Single (Participant)
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
- •Patients will have a DSM-IV diagnosis of TTM.
- •TTM symptoms for at least 4 months.
- •Scalp as primary site of hair pulling.
- •HPS score greater than or equal to 15 OR TTM Impact Scale score greater than
- •Written informed consent.
- •Men or women aged 18-65 years old.
- •Females of childbearing potential must have a negative serum beta-HCG pregnancy test.
排除标准
- •Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
- •Patients who, in the investigator's judgement, pose a serious suicidal or homicidal risk.
- •Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy.
- •History of seizure disorder.
- •Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder.
- •If there is a history of substance abuse, patients must be in remission at least 6 months.
- •Past trials of sertraline.
- •Currently being treated with behavioral therapy, specifically habit reversal training, for TTM.
- •Other medications for medical disorders that may interact with sertraline.
结局指标
主要结局
Clinical Global Impressions Scale change scores (week 2 versus 22)
时间窗: Week 2 to 22
Hair Pulling Scale change scores (week 0 versus 22)
时间窗: Week 0 to 22
TTM Impact Scale change scores (week 0 versus 22)
时间窗: Week 0 to 22
PITS (week 0 versus 22)
时间窗: Week 0 to 22
NIMH Scale (week 0 versus 22)
时间窗: Week 0 to 22
次要结局
- HAM-D-17 (week 0 versus 22)(Week 0 to 22)
- BDI (week 0 versus 22)(Week 0 to 22)
- BAI (week 0 versus 22)(Week 0 to 22)
- Q-LES-Q (week 0 versus 22)(Week 0 to 22)