ong-Term Extension Study of RO4917838 in Japanese Patients with Schizophrenia
Phase 3
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080221884
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 165
Inclusion Criteria
Patients who complete JN25535 study.
-Patients who hope extended administration of RO4917838.
-Patients who are considered appropriate for extended administration of RO4917838 by the investigator.
Exclusion Criteria
-Patients who are considered inappropriate for the study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Incidence of adverse events.<br>-Suicidality assessments<br><br>-Incidence of adverse events<br>-The items of the C-SSRS will be summarized and presented by individual listings.
- Secondary Outcome Measures
Name Time Method -PANSS total, factor and subscale scores<br>-Pharmacokinetics<br>-Mean change from baseline of JN25535 study in the PANSS total, factor and subscale scores<br>-plasma concentration of Ro4917838