An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole
Intervention description: Aripiprazole IM depot - 300 mg or 400 mg
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 709.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      The primary objective of this study was to continue to provide aripiprazole intramuscular
      (IM) depot treatment (400 milligrams [mg] or 300 mg) to participants with schizophrenia
      completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the
      secondary objective was to collect additional long-term safety data on aripiprazole IM depot
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a current diagnosis of schizophrenia, as defined by Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
             criteria, who completed the open-label extension Study 248 (completed Study 248 study
             completion visit, Week 52).

          -  Participants who, in the investigator's judgment, may benefit from continued
             participation in an aripiprazole IM Depot study.

          -  The baseline visit for Study 270 (which is the Week 52 visit of Study 248) and the
             first injection for Study 270 must occur within 4 weeks (which was defined as 28
             [-2/+10] days) of the last injection in Study 248.

          -  Participants who are able to provide written informed consent and/or consent obtained
             from a legally acceptable representative (as required by an Independent Review
             Board/Independent Ethics Committee (IRB/IEC), prior to the initiation of any
             protocol-required procedures.

          -  Participants able to understand the nature of the study and follow protocol
             requirements and who can read and understand the written word in order to complete
             patient-reported outcomes measures.

          -  Outpatient status.

        Exclusion Criteria:

          -  Participants with a current DSM-IV-TR diagnosis other than schizophrenia, including
             schizoaffective disorder, major depressive disorder, bipolar disorder, delirium,
             dementia, amnestic, or other cognitive disorders.

          -  Participants with borderline, paranoid, histrionic, schizotypal, schizoid, or
             antisocial personality disorder.

          -  Participants who currently meet DSM-IV-TR criteria for substance dependence, including
             alcohol and benzodiazepines, but excluding caffeine and nicotine.

          -  Participants with a significant risk of violent behavior or a significant risk of
             committing suicide based on the investigator's judgment.

          -  Participants who are known to be allergic, intolerant, or unresponsive to prior
             treatment with aripiprazole or other quinolinones.

          -  Participants with a history of neuroleptic malignant syndrome or clinically
             significant tardive dyskinesia at screening.

          -  Electroconvulsive therapy within 180 days prior to entry.

          -  Any participant who requires or may need any other antipsychotic medications during
             the course of the study.

          -  Aripiprazole IM Depot (including generic formulation) is commercially available in the
             participant's country.

          -  Other protocol specific inclusion/exclusion criteria may apply.