Clareo Health | A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot
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
diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
good physical health as determined by normal medical history, clinical laboratory results, electrocardiograms (ECGs) and physical examinations
ability to provide informed consent and/or consent from a legally acceptable representation
body mass index (BMI) of 18 to 35 kg/m\^2
You may not be if
sexually active males and females of child-bearing potential who are not practicing double barrier birth control or are not abstinent during the study plus 30 days for female or 90 days for males following the last dose of medication
history of drug or alcohol abuse within 6 months and/or positive urine drug screen
participants who consume alcohol beverages routinely
participants who consume alcohol beverages during the screening period
use of any antipsychotic medication, other prohibited psychotropic medication, and any cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 inducers within 14 days
use of any prescription medication unless approved by Medical Monitor or Study Director
history of current hepatitis or carrier of HBsAg (Hepatitis B surface antigen) and/or Hepatitis C Virus antibodies (anti-HCV)
females who are pregnant or lactating
participants who have participated in any clinical trial involving a psychotropic medication within one month prior to enrollment; participants who have participated in a previous IM Depot study within the last 1 year; patients who have previously enrolled and received study medication in an aripiprazole IM Depot clinical trial
donation of blood or plasma to a blood bank or in a clinical study (except a screening visit)within 30 days prior to enrollment
any major surgery within 30 days prior to enrollment
blood transfusion within 30 days prior to enrollment
evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations
patient represents a significant risk of committing suicide based on history
patients currently in an acute relapse
patients with Axis I (DSM-IV) diagnosis of schizoaffective or bipolar disorder
patients who are considered treatment-resistant to antipsychotic medication
patients with a history of neuroleptic malignant syndrome
any other sound medical reason as determined by the clinical investigator
