A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline)
研究概览
简要总结
The purpose of the study is to learn about the safety and effectiveness of oral (taken by mouth) topiramate in treating Sleep-Related Eating Disorder (SRED).
详细描述
This is a single center, 13-week, outpatient, randomized, double-blind, placebo-controlled, parallel group, pilot study of topiramate in subjects with Sleep-Related Eating Disorder (SRED). The primary objective of this study is to investigate the efficacy and safety of topiramate compared to placebo in the treatment of Sleep-Related Eating Disorder. SRED is a disorder that consists of out of control eating during the night with little or no awareness of the events. In this study we are comparing topiramate to placebo. A placebo is a pill that looks exactly like the study drug, but it does not have any active drug in it. Topamax (topiramate) is approved by the U.S. Food and Drug Administration (FDA) as a therapy for epilepsy, but topiramate has not been approved by the FDA for SRED.
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, Care Provider, Investigator)
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
- •Adults 18-65
- •Diagnosis of SRED
- •Must be able to swallow capsules and follow instructions
排除标准
- •Women who are pregnant or lactating
- •Other sleep disorders
- •Kidney or Liver disease
- •Night shift workers
- •Previous history of Topiramate or Topamax use for any condition
研究组 & 干预措施
Topiramate
Study medication arm, 25-300mg of Topiramate
干预措施: Topiramate or Placebo (Drug)
Placebo
Placebo arm of study, 25-300mg of sugar pill
干预措施: Topiramate or Placebo (Drug)
结局指标
主要结局
Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline)
时间窗: every 2 weeks for 10 weeks
Frequency of sleep-related eating episodes was measured as the number of nights a participant had an episode within the previous two weeks. The change was measured by comparing the last study visit (by the participant) from to the baseline results.
The Clinician Global Impression (CGI) Scale
时间窗: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)
The Clinician Global Impression (CGI) Scale is used by healthcare professionals to assess the overall severity of illness and change in a patient's condition over time. The scale ranges from 1 to 7, 1 being Very much improved and 7 being Very much worse. A participant with a score of 1 or 2 on the Clinician Global Impression scale was considered a "responder."
次要结局
- HbA1c (%)(Day 1 (First Study Visit) to Day 63 (Final Study Visit))
- Average Total Sleep Time (Hours)(Day 1 (First Study Visit) to Day 63 (Final Study Visit))
- Sleep Quality (Visual Analogue Scale or VAS)(Day 1 (First Study Visit) to Day 63 (Final Study Visit))
- The Patient Global Impression (PGI) Scale(Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit))
- Body Weight(every other week for 10 weeks)
研究者
John Winkelman, MD, PhD
Associate Professor of Psychiatry, Harvard Medical School
Massachusetts General Hospital