Open-Label Study of Levetiracetam in Body Dysmorphic Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)
研究概览
简要总结
The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for people with body dysmorphic disorder.
详细描述
Body dysmorphic disorder (BDD), a perceived defect in appearance (e.g., a "large" nose or facial "scarring"), is a relatively common disorder that causes marked distress and impairment in functioning. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs); however, response to SRIs is often only partial. About one third of patients do not respond to an SRI. Furthermore, patients may stop taking SRIs because of side effects (e.g., sexual side effects). For these reasons, additional monotherapy and SRI augmentation strategies are greatly needed.
Levetiracetam is primarily used as an antiseizure medication and has a wider safety margin than other antiepileptics. Preliminary scientific studies may suggest that it may be helpful for certain psychiatric symptoms and disorders. In the present study we propose to obtain pilot data on 1) levetiracetam monotherapy and 2) levetiracetam augmentation of SRIs in patients with BDD.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 18-65;
- •Current DSM-IV BDD or its delusional variant (delusional disorder, somatic type) for at least 3 months;
- •A minimum total score of 20 on the Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) (19);
- •Suitable for treatment in an outpatient setting
排除标准
- •Unstable medical illness, including renal failure or dialysis;
- •Myocardial infarction within 6 months;
- •Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- •A need for prn benzodiazepines, another antiepileptic medication, or an anticipated change in the dose of any concomitant medications while receiving treatment with levetiracetam;
- •Clinically significant suicidality, including a suicide attempt within the past two months;
- •Lifetime history of DSM-IV dementia, schizophrenia, or any other DSM-IV psychotic disorder that is not attributable to BDD;
- •Current or recent (past 3 months) DSM-IV substance abuse or dependence;
- •Initiation of ongoing psychotherapy from a mental health professional within 3 months prior to study baseline;
- •Ongoing cognitive-behavioral therapy from a mental health professional;
- •Previous treatment with levetiracetam;
- •Treatment with investigational medication, depot neuroleptics, or ECT within the past 3 months.
研究组 & 干预措施
open label
Open-label trial; all participants received levetiracetam
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)
时间窗: Baseline to end week 12
The BDD-YBOCS, a reliable and valid 12-item semi-structured clinician-administered scale assessed BDD severity during the past week. 38 items are rated from 0 (no symptoms) to 4 (extreme symptoms); range=0-48. This scale assesses preoccupation with the perceived appearance defects, associated compulsive behaviors, insight, and avoidance. A ≥30% decrease in total score indicated response.
次要结局
- Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms(Last week of treatment (week 12) or last week of treatment for early dropouts)
- Scores on Hamilton Depression Rating Scale(Pre- and post-treatment (week 12))
- Scores on Brown Assessment of Beliefs Scale(Pre- and post-treatment (week 12))
- Scores on Clinical Global Severity(Pre- and post-treatment (week 12))
- Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.(Last week of treatment (week 12))
- Scores on Beck Anxiety Inventory(Pre- and post-treatment (week 12))
- Scores on Social Phobia Inventory(Pre- and post-treatment (week 12))
- Scores on Social and Occupational Functioning Scale (SOFAS)(Pre- and post-treatment (week 12))
- Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms(Last week of treatment (week 12) or last week of treatment for early dropouts)
- Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.(Last week of treatment (week 12))
- Scores on Global Assessment of Functioning(Pre- and post-treatment (week 12))
- Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form(Pre- and post-treatment (week 12))