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临床试验/NCT00304161
NCT00304161已完成4 期

Depression Diagnosis and Treatment in Parkinson Disease

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2004年7月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
55
试验地点
2
主要终点
Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale

研究概览

简要总结

This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.

详细描述

Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer from depression. These individuals experience different symptoms than those who have depression alone. For example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. Depression treatment can help people with Parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. This study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with Parkinson's disease.

Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. All participants will report to the study site at baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the Inventory of Depressive Symptomatology (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. 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
30 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of idiopathic Parkinson's disease
  • IDS score greater than 21
  • Mini-Mental State Examination (MMSE) score greater than 15

排除标准

  • Recent deep brain stimulation
  • Currently participating in an antidepressant trial at a less than adequate dose and duration
  • Severe depression or depression with suicide ideation
  • History of liver toxicity
  • Unstable medical disease or comorbid psychiatric disease

研究组 & 干预措施

Atomoxetine

Active Comparator

Participants will receive 40-80mgs of atomoxetine orally once daily.

干预措施: Atomoxetine (Drug)

Placebo

Placebo Comparator

Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.

干预措施: Placebo (Drug)

结局指标

主要结局

Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale

时间窗: Week 8

The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a \>50% decrease in IDS-C score from baseline.

次要结局

  • Clinical Global Impression-Improvement Scale(Week 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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