Long-term Study of SM-13496 (Lurasidone Hydrochloride) in Adolescent Subjects with Schizophrenia

JRCT ID: jRCT2011210024

Registered date:28/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Schizophrenia
• Date of first enrollment: 28/07/2021
• Target sample size: 51
• Study type: Interventional
• Intervention(s): SM-13496 40 or 80 mg/day

Outcome(s)

• Primary Outcome: Safety and tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 18age old
• Gender: Both

Include criteria

-Subjects with DSM-IV-TR Axis I primary diagnosis of schizophrenia
-Subjects with 12-18 years of age at the time of 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.
-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

Exclude criteria

-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 mental retardation, neuroleptic malignant syndrome or any other neurologic disorder, or severe head trauma
-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

Related Information

• Primary Sponsor: Yabuuchi Kazuki