NCT03201757已完成3 期
A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give informed consent/assent as per local requirements
- •Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
- •Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
- •Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
- •Additional criteria may apply
排除标准
- •Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
- •Has a positive drug screen for drugs of abuse at study entry
- •Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
- •Additional criteria may apply
研究组 & 干预措施
ALKS 3831
Experimental
Coated bilayer tablet
干预措施: ALKS 3831 (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: Up to 48 months
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
时间窗: Up to 48 months
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients
次要结局
未报告次要终点
研究者
研究点 (1)
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