Confirmatory study of DSP-5423 in pediatric patients with schizophrenia.
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080221682
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
In pediatric patients with schizophrenia, the primary endpoint was the change in total PANSS score from baseline at week 6, and superiority of DSP-5423 8 or 16 mg/day to placebo was examined. The superiority of the 16 mg/day group was verified. Although the superiority was not verified in the 8 mg/day group, the PANSS total score change was greater than that in the placebo. The incidence of adverse events increased in the order of placebo, 8 and 16 mg/day. Most of adverse events were mild or moderate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 151
Patients who have a diagnosis of schizophrenia as defined by DSM-IV-TR
Patients aged 12-18 years etc.
Patients who fall under a contraindication listed in the LONASEN package insert
Patients who have ever been treated with blonanserin
Patients with Parkinson disease etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method