A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

Exclusion Criteria

• •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.