A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)
研究概览
简要总结
The primary objective of this study is to determine whether treatment with pimavanserin or quetiapine is associated with a greater improvement in psychosis when used in a routine clinical setting to treat hallucinations and/or delusions due to Parkinson's disease (PD) or dementia with Lewy bodies (DLB) - collectively referred to as Lewy body disease (LBD).
详细描述
Psychosis (hallucinations and delusions) is a common problem in Parkinson's disease (PD) and dementia with Lewy bodies (DLB). PD is a common neurodegenerative disorder that causes movement, cognitive, and psychiatric symptoms. DLB is a similar disorder, though causes more severe cognitive and psychiatric problems. Psychosis is highly prevalent among people with PD and DLB, often manifesting as visual hallucinations or paranoid delusions. Up to 60% of people with PD will experience psychosis over the course of their disease. Psychosis is associated with increased mortality, caregiver burden, and poorer quality of life.
More study is needed to determine the best way to treat psychosis in PD and DLB. Currently, both quetiapine and pimavanserin are used in clinical practice for psychosis in PD and DLB. However, few comparison studies have been done and it is unclear if one medication is superior to the other. This will be a clinical trial comparing quetiapine and pimavanserin among patients with psychosis due to PD or DLB requiring initiation of a medication. Patients will be randomized to quetiapine or pimavanserin and improvement in psychosis at 6 months will be compared between the groups.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients seen in the neurology clinic at UT Health San Antonio
- •Diagnosed with psychosis due to PD or DLB
- •Requiring initiation of an antipsychotic medication
- •Clinical equipoise between quetiapine and pimavanserin must exist
- •The prescribing provider must be comfortable prescribing and managing both quetiapine and pimavanserin
排除标准
- •Medical contraindication to either medication
- •Caregiver unavailable to complete NPI-Q
- •Currently taking an antipsychotic medication
- •Prescribing provider unwilling to manage either medication
研究组 & 干预措施
quetiapine
Elderly patients with dementia-related psychosis will be treated with quetiapine, an atypical antipsychotic indicated for the treeatment of: schizophrenia, bipolar I manic episodes and bipolar depressive episodes.
干预措施: Quetiapine (Drug)
pimavanserin
Elderly patients with dementia-related psychosis will be treated with pimavanserin, an atypical antipsychotic indicated for treatment of hallucinations and delusions associated with Parkinson's disease.
干预措施: Pimavanserin (Drug)
结局指标
主要结局
Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)
时间窗: Baseline to 6 months
Change in the Hallucinations + Delusions sub-score of the neuropsychiatric inventory questionnaire. Each NPI-Q item is scored by severity (1-3), and distress to caregiver (0-5), then added together (range 0-8) with a higher score indicating greater severity.
次要结局
- Neuropsychiatry Inventory Questionnaire (NPI-Q) total score(Baseline to 6 months)
- Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)(Baseline to 6 months)
- MDS-UPDRS part 3(Baseline to 6 months)
- Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)(Baseline to 6 months)
- Mortality(6 months)
- Time to discontinuation of per-protocol medication(Baseline to 6 months)
- Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)(Baseline to 6 months)
- CGIC, PGIC, CGI-C:CVR(Baseline to 6 months)