Schizophrenia
Conditions
Interventions
SM-13496 40 or 80 mg/day
Sponsors
Yabuuchi Kazuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | — |
Contacts
Public ContactProduct information center
Sumitomo Pharma Co., Ltd.
Outcome results
None listed