Dose-response study of SM-13496 in patients with schizophrenia [late Phase 2 study]
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080220090
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
-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.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method