NCT01914393已完成3 期
A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects
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
- 702
- 试验地点
- 88
- 主要终点
- Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)
研究概览
简要总结
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326
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
盲法说明
Open Label
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' participation in the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
- •Subject has completed Study D1050301 (Visit 9) OR
- •Subject has completed Study D1050325 (Visit 9) OR
- •Subject has completed Study D1050326 (Visit 8)
- •Subject is judged by the investigator to be appropriate for participation in a 104-week clinical trial in an outpatient setting involving open-label lurasidone treatment, and is able to comply with the protocol.
- •A reliable informant (eg, parent, legal guardian, or caregiver) must be available to accompany the subject at each visit. For subjects entering from Study D1050325, the reliable caregiver must also oversee the administration of the study drug throughout the study
- •Females who participate in this study:
- •are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-
- •practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR-
- •are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
- •Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
排除标准
- •Subject is considered by the investigator to be at imminent risk of suicide.
- •Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.
研究组 & 干预措施
Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Experimental
Lurasidone 20, 40, 60, 80 mg, flexibly dosed, once daily
干预措施: Lurasidone 20, 40, 60, 80 mg, flexibly dosed (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)
时间窗: During 104 Weeks (2-years) treatment period
The Safety population consists of all subjects who received at least one dose of study drug in this study.
次要结局
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in PANSS Positive Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in PANSS Negative Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in PANSS General Psychopathology Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in PANSS Excitability Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in the Clinical Global Impression -Severity Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Clinical Global Impression (CGI) - Severity Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
- Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
研究者
研究点 (88)
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