Escitalopram for the Treatment of Self-Injurious Skin Picking
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- MGH Skin Picking Scale
研究概览
简要总结
The purpose of this study is to determine the effectiveness of escitalopram in treating self-injurious skin picking.
详细描述
Purpose: Self-injurious skin picking is a problem documented to occur in 2 % of dermatology patients (Gupta, Gupta and Haberman, 1986) , and approximately 4% of the general population (Keuthen et al., 2000). It is widely under recognized, with medical sequelae that can include scarring, infections, lesions, and potentially life-threatening outcomes (O'Sullivan et al., 1999). In a prior study, fluoxetine was shown to be superior to placebo in treating self-injurious skin picking in a modest-sized double blind trial (Simeon et al., 1997). Similarly, open-label trials of other SSRIs, including sertraline (Kalivas, Kalivas and Gilman, 1996) and fluvoxamine (Arnold et al., 1999) resulted in reductions in skin-picking behavior. Escitalopram is a new SSRI that may have superior efficacy for the treatment of major depression and fewer side effects than other SSRIs. This study aims to assess the efficacy of escitalopram in patients who suffer from self-injurious skin-picking.
Comparisons: Subjects' initial scores on the CGI, HAM-D, SPTS, SPS, SPIS, BDI, BAI, QLESQ, & BDDQ will be compared to subjects' final scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Repetitive skin picking resulting in noticeable tissue damage and associated emotional distress and/or functional impairment.
- •Age 18-65 years old.
- •Duration of skin picking symptoms ≥ 6 months.
- •MGH Skin Picking Scale score ≥
- •Written informed consent.
- •Females of childbearing potential must have a negative serum or urinary beta-HCG test and be willing to use acceptable methods of birth control during study tenure.
排除标准
- •Pregnant women or females of childbearing potential who do not consent to use of a medically acceptable method of contraception.
- •Women who are breastfeeding.
- •Subjects who pose a serious suicidal or homicidal risk in the judgment of study investigators.
- •Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease.
- •Subjects with a dermatologic disorder that causes pruritis.
- •Patients on anticoagulant therapy.
- •History of seizure disorder.
- •Comorbid bipolar disorder, psychosis, organic mental disorder, borderline personality disorder or developmental disorder. Subjects with obsessive compulsive disorder (with primary symptoms other than compulsive skin picking).
- •History of substance dependence. If there is a history of substance abuse, subjects should be in remission for ≥ 6 months.
- •Current treatment with cognitive behavioral therapy for skin picking.
- •Current use of another SSRI medication.
- •Other medications for medical disorders that might interfere with escitalopram.
- •Current major depression or prescribed an antidepressant for major depression within the past 12 months.
- •More than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with another prior SSRI.
结局指标
主要结局
MGH Skin Picking Scale
Skin Picking Impact Scale
Skin Picking Treatment Scale
Clinical Global Impressions scale
次要结局
- Hamilton Depression Rating
- Beck Depression Inventory
- Beck Anxiety Inventory
- Quality of Life Enjoyment and Satisfaction Scale