A 50-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Subjects With Acute Manic or Mixed Episodes Associated With Bipolar I Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 322
- 主要终点
- Number of Participants Who Experienced Clinical or Laboratory Adverse Events
研究概览
简要总结
This study will investigate the safety and tolerability of a flexible dosing regimen of asenapine for the long-term treatment of manic or mixed episodes associated with bipolar disorder I in children and adolescents who completed study P06107.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed study P06107 and demonstrated acceptable degree of compliance with medication, visits and other study requirements
- •Must be male or a female who is not of childbearing potential and is not sexually active or is using a medically accepted method of contraception; or female who is not pregnant, or not lactating.
- •Must have a caregiver or responsible person living with the participant who agrees to provide support to ensure compliance with treatment, visits, and protocol procedures
排除标准
- •Positive pregnancy test or intention to become pregnant during the study
- •At imminent risk of self-harm or harm to others
- •Under involuntary inpatient commitment
- •Known serological evidence of human immunodeficiency virus (HIV) antibody
研究组 & 干预措施
Asenapine/Asenapine
Participants treated with asenapine in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg twice per day (BID), then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
干预措施: Asenapine (Drug)
Asenapine/Asenapine
Participants treated with asenapine in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg twice per day (BID), then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
干预措施: Rescue medication (Drug)
Placebo/Asenapine
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
干预措施: Asenapine (Drug)
Placebo/Asenapine
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
干预措施: Rescue medication (Drug)
结局指标
主要结局
Number of Participants Who Experienced Clinical or Laboratory Adverse Events
时间窗: Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks)
A clinical or laboratory adverse event is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
次要结局
- Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score(Baseline, Day 182 and Day 350)
- Percentage of Participants Who Were Y-MRS Total Score Remitters (Y-MRS ≤12)(Up to Day 350)
- Percentage of Participants Who Were Y-MRS Total Score Responders(Up to Day 350)
- Time to First Total Y-MRS 50% Response(Up to Day 350)
- Time to Failure to Maintain Response in Y-MRS Total Score(Up to Day 350)
- Change From Baseline in Clinical Global Impression Scale for Assessing Overall Bipolar Illness (CGI-BP Overall)(Baseline, Day 182 and Day 350)
- Change From Baseline in Clinical Global Impression Scale for Assessing Depression (CGI-BP Depression)(Baseline, Day 182 and Day 350)
- Change From Baseline in Clinical Global Impression Scale for Assessing Mania (CGI-BP Mania)(Baseline, Day 182 and Day 350)
- Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score(Baseline, Day 182 and Day 350)
- Percentage of Participants With Emergent Depression Based on CDRS-R(Up to Day 350)
- Percentage of CDRS-R Responders(Up to Day 350)
- Change From Baseline in Children's Global Assessment Scale (CGAS)(Baseline, Day 182 and Day 350)
- Percentage of Participants With a CGAS Score of Equal or Greater Than 70(Up to Day 350)
- Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaires (PQ-LES-Q) Total Score(Baseline, Day 182 and Day 350)
- Change From Baseline in PQ-LES-Q Overall Score(Baseline, Day 182 and Day 350)