A Double Blind Clinical Trial of DCS for Food Anxiety for Patients With Anorexia and Bulimia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100).
研究概览
简要总结
This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication) augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be reduced more in the DCS relative to placebo condition (c) participants in the DCS condition will have a greater increase in Body Mass Index.
详细描述
This study investigated if DCS vs placebo augmented food exposure in individuals with eating disorders.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified
排除标准
- •Pregnant or planning on becoming pregnant
- •Psychotic or Manic
研究组 & 干预措施
Setraline
250 mg DCS (setraline) versus placebo plus exposure
干预措施: Setraline (Drug)
placebo
Placebo group plus exposure
干预措施: Placebo vs Setraline (Drug)
结局指标
主要结局
Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100).
时间窗: Twice a week for two weeks
Anxiety will be measured at 4 sessions, twice a week for two weeks. Anxiety is combined in a repeated measures ANOVA to give total anxiety decreased across condition. Anxiety was measured using the Subjective Units of Distress (ranging from 1 to 100), where 1 is no anxiety and 100 is the most anxiety ever experienced.
Body Mass Index
时间窗: twice a week for two weeks and at initial assessment
BMI will be measured twice a week for two weeks and once before starting the trial. BMI is combined in a repeated measures ANOVA to give total BMI difference across condition.Difference in BMI from Time 1 to Time 4 was outcome.
次要结局
未报告次要终点