NCT04000009终止3 期
A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 235
- 试验地点
- 71
- 主要终点
- Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059
- •May benefit from longer term therapy with open-label pimavanserin treatment
- •If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception
排除标准
- •Is determined to be inappropriate for the study
- •Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
- •Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
研究组 & 干预措施
Drug - pimavanserin
Experimental
Pimavanserin 34 mg tablets
干预措施: Pimavanserin (Drug)
结局指标
主要结局
Treatment-emergent Adverse Events (TEAEs)
时间窗: 52 weeks
Number of patients with treatment emergent AEs
次要结局
未报告次要终点
研究者
研究点 (71)
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