Fluoxetine in Pediatric Body Dysmorphic Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in Total Score on the BDD-Y-BOCS Scale
研究概览
简要总结
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
详细描述
BDD usually begins in childhood or adolescence, but its treatment in pediatric populations has not been investigated. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs) such as fluoxetine (Prozac). Preliminary findings from case reports suggest that SRIs may also be effective in the treatment of BDD in children and adolescents. This study is the first large-scale, double-blind, placebo-controlled medication trial of fluoxetine for children and adolescents with BDD. Participants should be aged 16 or younger. Participation in this trial will last approximately 14 weeks.
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children and adolescents aged 16 and younger
- •BDD or its delusional variant present currently and for at least 6 months prior to the study
- •Ability to communicate meaningfully with the investigators and competent to provide written assent
排除标准
- •Presence of Schizophrenia or Bipolar Disorder
- •Recent suicide attempt or suicidal ideations that warrant hospitalizations
- •Previous allergic reaction to fluoxetine
- •History of a seizure disorder
研究组 & 干预措施
Fluoxetine
Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
干预措施: Fluoxetine (Drug)
Placebo
Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total Score on the BDD-Y-BOCS Scale
时间窗: Baseline compared to the study endpoint (week 12) [two time points]
To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.
次要结局
未报告次要终点
研究者
Eric Hollander
Prof. Psychiatry & Behavioral Sciences
Montefiore Medical Center