Schizophrenia
Conditions
Sponsors
Otsuka Pharmaceutical Co., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) 2)Patients capable of staying at the trial site from the day before investigational medicinal product (IMP) administration to the 8th day following IMP administration in both Period 1 and Period 2 3)Patients with a body mass index [BMI = body weight (kg)/height (m)2] of 18.5 or higher and lower than 35.0 at screening 4)Persons who provide written informed consent before commencement of any trial-related procedures and whom the investigator or subinvestigator judges to be capable of following all the conditions of this trial 6)Patients who, in the judgement of the investigator or subinvestigator, have stable psychotic symptoms maintained by administration of an antipsychotic (other than clozapine) within the dosing range indicated separately, before commencement of investigational medicinal product (IMP) administration
Exclusion criteria
Exclusion criteria: 1)Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, personality disorder, etc) based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (However, this exclusion does not apply to caffeine- or tobacco-related disorders) 2)Patients who fail to meet the specified requisite washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of these drugs or foods during the study period 3)Patients who have previously undergone gastrointestinal surgery that could affect pharmacokinetic evaluations 4)Patients who are using clozapine at the time of informed consent 5)Patients who have received electro-convulsive therapy within 60 days before commencement of IMP administration 6)Patients with clinically problematic disorders of the nervous system, liver, kidneys, metabolic system, blood, immune system, cardiovascular system, lungs, or digestive system (However, such patients may be included if the condition is mild or well-controlled and is considered to not affect safety or pharmacokinetic evaluations.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics Plasma concentrations and PK parameters of brexpiprazole after single and multiple doses of QW formulation | — |
Countries
Japan
Outcome results
None listed