Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale
研究概览
简要总结
This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing anxiety in people with Parkinson's disease.
详细描述
Anxiety is a serious medical condition that worsens quality of life by negatively affecting peoples thoughts, feelings, and ability to function normally. Anxiety can affect anyone, but people with Parkinson's appear to be at a much higher risk with an estimated 40% or more suffering from anxiety. Parkinson's is a neurological disorder that causes tremor and other problems with normal movements. The disease symptoms are believed to be caused in large part by the loss of dopamine producing cells in the midbrain. Anxiety in Parkinson's may be associated with the loss of dopamine caused by the disease and therefore may respond to dopamine based treatments. This study will evaluate the effectiveness of the rotigotine transdermal patch, a dopamine replacement medication, in reducing symptoms of anxiety in people with Parkinson's disease.
Participants in this double-blind study will be randomly assigned to receive either rotigotine or a placebo patch for 8-weeks. All participants will be evaluated at the study site at baseline and weeks 2, 4, and 8. Psychiatric, cognitive, and movement assessments will be performed along with a review of anxiety symptoms. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 Anxiety Disorder
- •Stable medical history and general health
- •On stable anti-parkinsonian therapy for 2 weeks before enrollment
排除标准
- •Unstable medical disease of comorbid psychiatric disease
- •Subjects with less than one year duration of Parkinson's
- •Current treatment with a dopamine agonist
研究组 & 干预措施
rotigotine
rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
干预措施: rotigotine transdermal patch (Drug)
placebo
placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale
时间窗: Baseline, weeks 2, 4 and 8
The main outcome measure for this study was change in anxiety symptom severity over the course of the study. Anxiety severity was measured using the Hamilton Anxiety Rating Scale (HARS).The HARS is a 14-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 56, with scores greater than 17 indicating mild severity, scores between 18 and 24 indicating mild to moderate severity and scores greater than 25 indicating moderate to severe severity.
次要结局
- Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale(Baseline, weeks 2, 4 and 8)