NCT00437125已完成4 期
An Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death
研究概览
简要总结
This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are outpatients, male or female, 30 through 75 years of age
- •Meet diagnostic criteria for major depression episode and a clinical diagnosis of idiopathic Parkinson's disease
- •Have a clinician-rated 17-item Hamilton Depression Rating Scale (HAMD17) total score greater than or equal to 15, a Beck Depression Inventory (BDI) total score greater than or equal to 13 and a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 3 at both Visit 1 and Visit 2
- •Have satisfactory cognitive function
- •Have been held on stable dosage of antiparkinsonian medications for at least 4 weeks immediately prior to Visit 1
排除标准
- •Any current primary psychiatric diagnosis other than Major depressive episode, and any personality disorder that could interfere with the compliance with the study protocol
- •Atypical or secondary parkinsonism due to drugs or diseases with features of Parkinson's disease
- •Motor conditions for which it is to be expected to change the antiparkinsonian treatment during the course of the study
- •Clinically significant laboratory abnormalities or serious, unstable medical illness
- •Lack of response of current episode to two or more adequate courses of antidepressant therapy
研究组 & 干预措施
Duloxetine
Experimental
Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
干预措施: Duloxetine hydrochloride (Drug)
结局指标
主要结局
Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death
时间窗: baseline through 12 weeks
The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death.
次要结局
- Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score(baseline, 12 weeks)
- Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale(baseline, 12 weeks)
- Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)(baseline, 4 weeks, 8 weeks, 12 weeks)
- Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score(baseline, 12 weeks)
- Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale(baseline, 12 weeks)
- Patient's Global Impression-Improvement at Week 12(12 weeks)
- Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score(baseline, 12 weeks)
- Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)(baseline, 12 weeks)
- Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score(baseline, 12 weeks)
- Average Change From Baseline to 12 Weeks in Blood Pressure(baseline through 12 weeks)
- Average Change From Baseline to 12 Weeks in Heart Rate(baseline through 12 weeks)
- Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study(baseline through 12 weeks)
- Laboratory Analytes(baseline through 12 weeks)
- Number of Participants Who Responded to Treatment by 12 Weeks(12 weeks)
- Number of Participants Who Reached Remission by 12 Weeks(12 weeks)
研究者
研究点 (1)
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