Hydroxyzine Effects on Meal-Related Anxiety in Underweight Adolescents and Young Adults Diagnosed With an Eating Disorder - A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Self-reported anxiety
研究概览
简要总结
The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment of meal-related anxiety in adolescents and young adults 8 to 25 years of age diagnosed with an eating disorder who are underweight. The investigators want to find out if hydroxyzine given before meals will improve meal-related anxiety compared to no hydroxyzine.
详细描述
This study is a practiced-based pilot study in follow-up to clinical observations made by our treatment team that hydroxyzine attenuates meal-related anxiety and improves treatment adherence in patients with a diagnosis of Anorexia Nervosa (AN) (excluding the amenorrhea criterion) or Eating Disorder Not Otherwise Specified (EDNOS) specifically with low BMI (≤ 18). To our knowledge, hydroxyzine has never been formally investigated in treating meal-related anxiety and improving outcomes in patients with AN or EDNOS specifically with low BMI (≤ 18).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the Intensive Structured Living Unit (ISL) at Melrose Institute for treatment of an eating disorder that meets DSM-IV criteria for Anorexia Nervosa (excluding the amenorrhea criterion), or Eating Disorder Not Otherwise Specified, specifically with BMI (≤ 18)
- •Age 8-25 years old at admission to ISL.
- •Weight ≥ 15 kg at admission to ISL.
- •Stable psychotropic and/or sedative medications for at least (≥) 6 weeks
排除标准
- •Age < 8 years
- •Age ≥ 25 years
- •Weight < 15 kg at admission to ISL
- •Prolonged QT interval on ECG at admission to ISL
- •Current substance or alcohol abuse or dependence
- •Malabsorption syndrome or inability to take oral medications
- •History of hydroxyzine intolerance or hypersensitivity
- •History of Type 1 Diabetes Mellitus
- •History of angle closure glaucoma
- •Currently on another clinical trial
- •Pregnancy
研究组 & 干预措施
Hydroxyzine
Hydroxyzine given TID
干预措施: Hydroxyzine (Drug)
Hydroxyzine
Hydroxyzine given TID
干预措施: hydroxyzine HCL (Drug)
Sugar Pill
Placebo given 3 times per day
干预措施: Placebo (Other)
结局指标
主要结局
Self-reported anxiety
时间窗: 3 weeks
次要结局
未报告次要终点