A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: aripiprazole IM depot; aripiprazole tablets
Intervention description: Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.; Aripiprazole tablets 10 mg once daily in the morning for 14 days.
Intervention MeSH terms: Aripiprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of
      aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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