Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole IM Depot
Intervention description: 300mg or 400mg
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1081.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Aripiprazole; IM Depot; Schizophrenia; Intramuscular

Summary:

      To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance
      treatment in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are able to provide written informed consent and/or consent obtained from
             a legally acceptable representative (as require by IRB/IEC), prior to the initiation
             of any protocol-required procedures.

          -  Male and female subjects 18 to 65 years of age, inclusive, at time of informed
             consent.

          -  Subjects who complete Studies 246/247 or who withdrew from the double-blind
             maintenance phase of either study (Phase 4 of Study 246 or Phase 3 of Study 247), or
             new subjects not participating in Studies 246/247.

          -  # Subjects who, in the investigator's judgment, require chronic treatment with an
             antipsychotic medication.

          -  Subjects able to understand the nature of the study and follow protocol requirements,
             including the prescribed dosage regimens, tablet ingestion, IM depot injection,
             discontinuation of prohibited concomitant medications, who can read and understand the
             written word in order to complete patient-reported outcomes measures, and who can be
             reliably rated on assessment scales.

        Exclusion Criteria:

          -  Subjects 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. Also, subjects with borderline,
             paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.

          -  Subjects with schizophrenia that are considered resistant/refractory to antipsychotic
             treatment by history or response only to clozapine.

          -  Subjects with a significant risk of violent behavior or a significant risk of
             committing suicide based on history or investigator's judgment.

          -  Subjects who currently meet DSM-IV-TR criteria for substance dependence; including
             alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug
             screens for cocaine.

          -  Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment
             with aripiprazole or other quinolinones.

          -  Subjects with a history of hypersensitivity to antipsychotic agents.

          -  Subjects with a history of neuroleptic malignant syndrome or clinically significant
             tardive dyskinesia at screening.