NCT03482882已完成2 期
An Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 20
- 主要终点
- Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score
研究概览
简要总结
The purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with Parkinson's disease.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations
- •Has a clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features:
- •rest tremor
- •bradykinesia and/or akinesia
- •postural and gait abnormalities
- •Meets clinical criteria for depression with Parkinson's disease as listed in the NINDS/NIMH Guidelines
- •If currently taking an anti-depressant, is being treated with only one SSRI or SNRI antidepressant at a dose within the US FDA-approved dose range. Subjects who are currently taking a second antidepressant or antidepressant augmentation agent at a sub-therapeutic dose or for an inadequate duration at Screening, and can be discontinued from this agent before the Baseline visit (in the opinion of the Investigator), may be eligible for the study.
- •Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening
- •If the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception
排除标准
- •Use of an antipsychotic within 3 weeks or 5 half-lives of Baseline (whichever is longer)
- •Had a myocardial infarction within the 6 months prior to Screening
- •Has a known personal or family history or symptoms of long QT syndrome
- •Evidence of severe or medically significant hepatic or renal impairment on laboratory tests as assessed by the Investigator or Medical Monitor
- •Has a history of PD psychosis, schizophrenia, or other psychotic disorder, or bipolar I or II disorder.
- •Actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
- •Is pregnant or breastfeeding
- •Has previously been treated with pimavanserin or is currently taking pimavanserin
- •Has a sensitivity to pimavanserin or its excipients
- •Is judged by the Investigator or the Medical Monitor to be inappropriate for the study
- •Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
研究组 & 干预措施
Drug - pimavanserin
Experimental
干预措施: Pimavanserin (Drug)
结局指标
主要结局
Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score
时间窗: From baseline to Week 8
The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression.
次要结局
- Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6(2, 4, and 6 weeks from baseline)
- Clinical Global Impression-Improvement (CGI-I)(At Week 8)
- Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S)(From baseline to Week 8)
- Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score(From baseline to Week 8)
- Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score(From baseline to Week 8)
- The Number (or Percentage) of Responders(From baseline to Week 8)
- Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)(From baseline to Week 8)
研究者
研究点 (20)
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