Study of Antidepressants in Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 18
- 主要终点
- Change in Hamilton Depression Rating Scale (HAM-D) Scores
研究概览
简要总结
The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.
详细描述
Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.
The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.
This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible you must be:
- •30 years old or older
- •diagnosed with Parkinson's disease
- •experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping
排除标准
- 未提供
研究组 & 干预措施
paroxetine
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
干预措施: paroxetine (Drug)
venlafaxine extended release
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
干预措施: venlafaxine (Drug)
placebo
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
干预措施: placebo (Other)
结局指标
主要结局
Change in Hamilton Depression Rating Scale (HAM-D) Scores
时间窗: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.
次要结局
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Beck Depression Inventory II (BDI-II)(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Geriatric Depression Rating Scale (GDS)(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Brief Psychiatric Rating Scale (BPRS)(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS)(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Snaith Clinical Anxiety Scale (CAS)(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Pittsburgh Sleep Quality Index (PSQI)(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Short Form 36 Health Survey - Mental Component Summary(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Short Form 36 Health Survey - Vitality(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Short Form 36 Health Survey - Role-Emotional(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
- Change in Short Form 36 Health Survey - Mental Health(from the beginning (0 weeks) to end (12 weeks) of the double-blind phase)
研究者
Irene Richard
Irene Richard, MD
University of Rochester