An Open-label, Long-term Study of SM-13496 (Lurasidone Hydrochloride) in Adolescent Subjects with Schizophrenia [Phase 3]

Yabuuchi Kazuki0 个研究点目标入组 51 人开始时间: 2021年7月28日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•Subjects with DSM-IV-TR Axis I primary diagnosis of schizophrenia
•-Subjects with 12-18 years of age at the time of consent
•-Subjects aged less than 18 years at the time of informed consent:Subjects and legally acceptable representative have received and understood sufficient explanation including the study objectives and content, as well as the anticipated therapeutic effect, pharmacological action, and risks. And written voluntary informed consent has been obtained from the legally acceptable representative. Informed assent from the subject also must be obtained before initiation of the screening period. Subjects aged 18 years at the time of informed consent: Subjects have received and understood sufficient explanation including the study objectives and content, as well as the anticipated therapeutic effect, pharmacological action, and risks. And written voluntary informed consent has been obtained from the subject.
•-PANSS total score >=60 at screening and baseline
•-Female subjects of childbearing potential must have a negative pregnancy test (urine) at screening. (Check human chorionic gonadotropin beta subunit [beta-hCG] with urine.)
•-Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use appropriate contraception to avoid pregnancy

•-Subjects with a DSM-IV-TR Axis I or Axis II diagnosis other than schizophrenia that has been prioritized over schizophrenia for drug treatment within 3 months prior to screening
•-Past or current history of neuroleptic malignant syndrome ,any other neurologic disorder or severe head trauma, or current history of mental retardation
•-PANSS total score >=100 at screening or baseline
•-Females who are pregnant, suspected to be pregnant, or breastfeeding
•-Subjects who previously received lurasidone
•-Subjects who answered ''Yes'' to the C-SSRS ''Suicidal Ideation'' Item 4 or 5 at screening or baseline
•-Subjects with any clinically evident abnormal finding in laboratory values or vital signs at screening that is judged by the Investigator to be clinically significant

发起方

Yabuuchi Kazuki