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
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A current diagnosis of schizophrenia or bipolar I disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Body mass index of 18 to 35 kilograms per meter square (kg/m\^2).
On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening.
You may not be if
Participants who have:
* Met DSM-5 criteria for substance use disorder within the past 180 days.
* A positive drug screen for drugs of abuse
Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or participants who use more than one antipsychotic or mood stabilizer(s) medication at screening.
Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP). A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants.
Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations.
Participants currently in an acute relapse of schizophrenia.
Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, participants with borderline, paranoid, histrionic, or antisocial personality disorder.
Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
History of or current hepatitis or acquired immunodeficiency syndrome or carriers of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (anti-HCV), and/or Human immunodeficiency virus (HIV) antibodies.
Participants deemed intolerant of receiving injections.
Participants who have had electroconvulsive therapy within 2 months of administration of IMP.
