Bupropion and Restless Legs Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.
研究概览
简要总结
The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).
详细描述
Adult patients with moderate to severe RLS will be recruited for the study. Those on medications which treat RLS will be asked to discontinue the medications for two weeks prior to beginning the study. All participants will be screened with Beck Depression Inventory, International Restless Legs Syndrome Study Group (IRLSSG) severity scale, and Clinical Global Impression of Improvement (CGI-I) scale. An ordinal scale (i.e. rate symptoms from 1-8) will also be obtained. Participants will be randomized to a placebo or medication group. Those in the medication group will be given 150 mg of bupropion at night for six weeks. Others will receive similar-appearing placebo. Participants will be called at the end of weeks one, two, four and five to assess symptom severity based on IRLSSG scale, and to determine if they are experiencing any adverse effects. At three weeks and six weeks, participants will return to the clinic to complete all four of the initial forms, the Beck Depression Inventory, IRLSSG severity scale, ordinal scale, and CGI-I.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical diagnosis of Restless Legs Syndrome
- •Severity Scale score 15 or higher
排除标准
- •History of seizures
- •History of alcohol use greater than 2 drinks per day or occasional binges of 5 or more drinks per day
- •Suicidal thoughts/ideations
- •Inability to return for follow up appointments at 3 and 6 weeks
- •Lack of access to telephone
- •Eating disorder
- •Age less than 18
- •Pregnancy
- •Unwillingness or inability to discontinue any RLS medications
研究组 & 干预措施
1
Participants will receive 150MG Bupropion nightly.
干预措施: Bupropion (Drug)
2
Participants will receive matching placebo capsule nightly.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.
时间窗: Baseline, three weeks, and six weeks
Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.
Clinical Global Impression - Improvement Scale
时间窗: three weeks and six weeks
Ordinal Scale (i.e., 1-8) of Symptom Severity
时间窗: three weeks and six weeks
次要结局
未报告次要终点
研究者
Max Bayard
Associate Professor of Family Medicine
East Tennessee State University