Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole IM Depot
Intervention description: Aripiprazole IM Depot 400 mg or 300 mg
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 66 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program
      and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the
      treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive
      treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297)
      will allow the subjects who complete Trial 291 to enter this open label trial at the
      investigator's discretion, where additional safety and tolerability data will be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects 18 to 66 years of age, inclusive, at the time of informed
             consent.

          -  Subjects who are able to provide written informed consent (as required by IRB/IEC)
             prior to the initiation of any protocol-required procedures.

          -  Ability, in the opinion of the investigator, to understand the nature of the trial and
             follow protocol requirements, including the prescribed dosage regimens, tablet
             ingestion, and discontinuation of prohibited concomitant medication, and to be
             reliably rated on assessment scales.

          -  Subjects who have met the completion criteria in the 31-12-291 registrational trial
             for the acute treatment of adults with schizophrenia

          -  Subjects who, in the investigator's judgment, require chronic treatment with
             antipsychotic medication and would benefit from extended treatment with an IM depot
             formulation.

          -  Outpatient status at the Week 12 in Trial 291, with the exception of those subjects
             eligible to enter Trial 297 due to a positive interim analysis.

        Exclusion Criteria:

          -  Sexually active males of childbearing potential who do not agree to practice 2
             different methods of birth control or remain abstinent during the trial and for 180
             days after the last dose of trial medication. Sexually active Women of Childbearing
             Potential who do not agree to practice 2 different methods of birth control or remain
             abstinent during the trial and for 150 days after the last dose of trial medication.

          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving IMP in this trial.

          -  Subjects experiencing acute depressive symptoms within the past 30 days, according to
             the investigator's opinion, that requires treatment with an antidepressant.

          -  Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers
             during the course of the trial.

          -  Subjects with a significant risk of violent behavior; who represent a risk of
             committing suicide; or who in the clinical judgment of the investigator present a
             serious risk of suicide.

          -  Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after
             completion of Trial 291.

          -  Subjects likely to require prohibited concomitant therapy during the trial

          -  Laboratory test and ECG results which are exclusionary

          -  Any subject who, in the opinion of the investigator or medical monitor, should not
             participate in the trial