ong term study of RG1678(RO4917838) in Japanese schizophrenic patients.
Phase 3
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080221587
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 165
Inclusion Criteria
Adult patients, aged 18 years and above
-Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
-Predominant negative symptoms or Sub-optimally controlled symptoms
-With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)
Exclusion Criteria
-Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
-Body Mass Index (BMI) <18.5 or >40
-History of neuroleptic malignant syndrome.
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>Mean change from baseline in the PANSS total, factor and subscale scores