The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
研究概览
简要总结
Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet it frequently remains untreated and there have been no clinical trials dedicated to evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is effective for the treatment of generalized anxiety disorder in the general and elderly population. It is not known if it is effective for the treatment of anxiety in Parkinson's disease. This is a single-center, placebo-controlled, double-blind design with participants randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg twice daily) or placebo for 12 weeks.
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
- 否
入选标准
- •Diagnosis of idiopathic PD by UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
- •Significant anxiety as determined by the self-rated Parkinson Anxiety Scale (score ≥ 14)
- •Able to provide written informed consent
- •At least 18 years of age
排除标准
- •Diagnosis of atypical or secondary parkinsonism
- •Concomitant treatment with an MAO inhibitor within the 14 days prior to screening visit
- •Significant renal or hepatic impairment
- •Significant cognitive impairment defined as MOCA score < 23
- •On-going depression with suicidal or homicidal ideation and concern for patient safety based on clinical determination by the investigator
- •Allergy or intolerance to study drug, matching placebo, or their formulations
- •History of prior exposure to study drug
- •Lactating or pregnant woman
- •Concomitant treatment with a disallowed medication (detailed in section 6.2)
- •Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- •Concomitant treatment with an anxiolytic or antidepressant will be allowed however potential participants who had dosage changes in the 30 days prior to the screening visit will be excluded
- •Use of an investigational drug within 30 days prior to screening visit
- •Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation
- •Dysphagia defined as a score of ≥ 2 on MDS-UPDRS Item 2.3 Chewing and Swallowing
研究组 & 干预措施
Buspirone
Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks.
干预措施: Buspirone (Drug)
Placebo
Flexible dosage placebo for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
时间窗: 12 weeks
次要结局
- Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks(12 weeks)
- Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks(12 weeks)
- Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks(12 weeks)
- Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks(12 weeks)
- Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)(baseline to 12 weeks)
- Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks(12 weeks)
- Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks(12 weeks)
研究者
Irene Richard
Professor of Neurology
University of Rochester