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
18–35
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Had the start of their first schizophrenia episode ≤ 5 years before the time of consent.
Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).
Have a Positive and Negative Syndrome Scale (PANSS) Total Score of ≤ 80 at screening and baseline.
Exhibit schizophrenia symptoms with a score ≥ 4 on the PANSS for ≥1 items related to active social avoidance, emotional withdrawal, passive/apathetic social withdrawal, and difficulty in abstract thinking.
Have a diagnosis of schizophrenia made at least 6 months prior to screening as confirmed by subject, caregiver, or documented history.
You may not be if
Subjects who have been hospitalized for psychotic symptoms within the last 6 months.
Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history or who have a history of failure to respond to clozapine or response to clozapine treatment only.
Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, MDD, bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders.
Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant.
Subjects with clinically significant tardive dyskinesia at enrollment, as determined by a score of\>= 3 on Item 8 of the AIMS at screening or baseline.
Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment of akathisia at screening or baseline.
Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding nicotine.
