NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2011210024

Registered date:28/07/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSchizophrenia
Date of first enrollment28/07/2021
Target sample size51
Countries of recruitment
Study typeInterventional
Intervention(s)SM-13496 40 or 80 mg/day

Outcome(s)

Primary OutcomeSafety and tolerability
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 12age old
Age maximum<= 18age old
GenderBoth
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 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
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 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

Related Information

Contact

Public contact
Name Product information center
Address 6-8, Doshomachi 2-chome,Chuo-ku,Osaka,Osaka 541-0045,Japan Osaka Japan 541-0045
Telephone +81-120-034-389
E-mail cc@sumitomo-pharma.co.jp
Affiliation Sumitomo Pharma Co., Ltd.
Scientific contact
Name Kazuki Yabuuchi
Address 6-8, Doshomachi 2-chome,Chuo-ku,Osaka,Osaka 541-0045,Japan Osaka Japan 541-0045
Telephone +81-120-034-389
E-mail cr@sumitomo-pharma.co.jp
Affiliation Sumitomo Pharma Co., Ltd.