Repeated administration of DSP-5423P in patients with Schizophrenia
Phase 1
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080222373
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Patients who have a diagnosis of schizophrenia as defined by DSM-IV-TR
Exclusion Criteria
- Patients who fall under a contraindication listed in the LONASEN package insert
- Patients with Parkinson disease, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Safety and Tolerability<br>Adverse event monitoring<br>Change in DIEPSS total score after multiple administration of DSP-5423P
- Secondary Outcome Measures
Name Time Method - Plasma Concentration of Blonansein and its metabolites<br>- PANSS total score and CGI-S score<br>- Change in PANSS total score and CGI-S score after multiple administration of DSP-5423P