Schizophrenia
Conditions
Interventions
investigational material(s)
Generic name etc : SM-13496
INN of investigational material :
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Investigational material :
Sponsors
Dainippon Sumitomo Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients who meet the ICD-10 diagnostic criteria for schizophrenia -Fresh schizophrenic patients suffering from an initial or recurrent episode or schizophrenic patients receiving antipsychotic drugs, who meet the following inclusion criteria at the time of enrollment a) Patients with hallucinations and delusions in the foreground b) Patients with delusions in the foreground c) Patients with loss of spontaneity and blunted affect in the foreground: Type 1 (fresh, hebephrenic) d) Patients with loss of spontaneity and blunted affect in the foreground: Type 2 (chronically illed, fixed symptoms) e) Patients presenting with neurosis-like symptoms in the foreground f) Patients presenting with depressive symptoms in the foreground -Patients aged 18 to less than 65 at the time of informed consent acquisition etc. -Patients with a history of malignant syndrome, water intoxication, paralytic ileus or with strong suicidal ideation -Patients with Parkinson's disease -Patients with HbA1C level of 8.0% or greater, or whose glycoalbumin level is 23.0% or greater -Patients who have received electroconvulsive therapy within 6 months (180 days) prior to the first dose of the investigational product etc.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Changes in BPRS and PANSS total scores from baseline etc Safety: Changes in DIEPSS score from baseline etc | — |
Outcome results
None listed