Schizophrenia
Conditions
Interventions
investigational material(s)
Generic name etc : OPC-34712 High dose
INN of investigational material : -
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Investigational
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria - Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent - Patients who are experiencing acute exacerbation of psychotic symptoms
Exclusion criteria
Exclusion criteria: - Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product - Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator - Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis I criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1.Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score. 2.Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score. 3.Change in CGI-S Score from Baseline to Week 6 4.CGI-I Score at Week 6 safety Percentage of Participants With Treatment-emergent adverse event(TEAE) | — |
Countries
Japan
Outcome results
None listed