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) studied | Schizophrenia |
Date of first enrollment | 28/07/2021 |
Target sample size | 51 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | SM-13496 40 or 80 mg/day |
Outcome(s)
Primary Outcome | Safety and tolerability |
---|---|
Secondary Outcome |
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 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
Primary Sponsor | Yabuuchi Kazuki |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
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 |
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 |
cr@sumitomo-pharma.co.jp | |
Affiliation | Sumitomo Pharma Co., Ltd. |