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.
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female subjects between 18 and 55 years of age, inclusive, with a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria.
Body mass index of 19 to 35 kg/m2.
You may not be if
Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of trial medication for all female subjects.
Subjects presenting with a first episode of schizophrenia or schizoaffective disorder based on the clinical judgment of the investigator.
Subjects who have received continuous medication therapy to treat schizophrenia or schizoaffective disorder for less than 6 months prior to washout.
Subjects with schizophrenia or schizoaffective disorder that are considered resistant/refractory to antipsychotic treatment by history, who have a history of failure to clozapine, or who are responsive only to clozapine treatment.
Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia or schizoaffective disorder.
Hospitalization for an exacerbation of schizophrenia or schizoaffective disorder within 3 months prior to randomization.
Subjects who have a history of or who have evidence of other medical and/or neurological conditions that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the trial.
Subjects with a history of neuroleptic malignant syndrome.
Subjects with a history of seizure disorder.
Subjects who meet DSM-IV-TR criteria for substance dependence within 6 months prior to randomization.
