Ziprasidone Open Label Study (Phase II)
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080221713
- Lead Sponsor
- Meiji Seika Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 20
Patient with Schizophrenia as defined with DSM-IV-TR who meet all inclusion criteria and do not meet all exclusion criteria.
- Patients with a PANSS total score between 50 and 120, inclusive, at the baseline visit
- Patients who have been explained study objectives, methods and other aspects of study, and can give voluntary consent in writing
- Patients of treatment resistant schizophrenia
- Patients with a primary active mental illness diagnosis other than schizophrenia
- Patients with a history of significant cardiovascular disease
- Patients with treated but uncontrolled hematological, hepatic, renal, respiratory, gastrointestinal, endocrine, or neurological diseases, or other clinically significant concomitant physical diseases
- Patients who had received other investigational drugs within 90 days prior to baseline
- Patients considered not to be eligible by the investigator
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events and Adverse drug reactions<br>Incidence
- Secondary Outcome Measures
Name Time Method PANSS<br>Changes from baseline