Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otsuka Pharmaceutical Development & Commercialization, Inc.
With
Otsuka Pharmaceutical Co., Ltd.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies
Would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry
Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:
Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80
Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness
Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately ill)
You may not be if
Are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator
Have been hospitalized \> 21 days for the current acute episode at the time of the baseline visit
Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.
Improvement of ≥ 20% in total PANSS score between the screening and baseline assessments.
