NCT04987229Enrolling By Invitation3 期
Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects With Schizophrenia 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
- Enrolling By Invitation
- 入组人数
- 236
- 试验地点
- 36
- 主要终点
- Incidence of adverse events
研究概览
简要总结
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia 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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subject had terminated early from Study ALKS 3831-A312 due to the clinically significant weight gain criterion.
- •Subject will benefit from continued therapy with OLZ/SAM per clinical judgment.
- •Subject is able to be treated on an outpatient basis.
- •Subject must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient.
- •Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
- •Subject agrees to abide by the contraception requirements specified in the protocol for the duration of the study.
排除标准
- •Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior since the last visit.
- •Subject 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 requirement.
- •Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
- •Subject has a positive test for opioids.
- •Subject has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the study and for 90 days after any study drug administration.
研究组 & 干预措施
All subjects
Experimental
All subjects will receive OLZ/SAM at a dose determined by the Investigator and based on the olanzapine dosing received in the antecedent study (ALKS 3831-A311 or ALKS 3831-A312 ENLIGHTEN-Youth)
干预措施: OLZ/SAM (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 52 weeks
次要结局
未报告次要终点
研究者
研究点 (36)
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