Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole (Abilify®) IM Depot Injection
Intervention description: 400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.
Number of injections: 6. Subjects have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2013.
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 493.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      The purpose of this study is to compare retrospective hospitalization rates of schizophrenic
      patients treated with oral antipsychotics to prospective hospitalization rates of these
      patients treated with IM depot aripiprazole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are able to provide written informed consent. If the IRB requires consent
             by a legally acceptable representative in addition to the subject, all required
             consents must be obtained prior to any protocol-required procedure.

          -  Male and female subjects 18 to 65 years of age, inclusive.

          -  Current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a history of
             the illness for at least 1 year (12 months).

          -  Subjects who in the investigator's judgment would benefit from extended treatment with
             a long-acting injectable formulation.

          -  Subjects who have at least 1 inpatient psychiatric hospitalization in the 4 years (48
             months) prior to screening, but have been managed as outpatients for the 4 weeks prior
             entering the study.

          -  Subjects must have been on oral antipsychotic treatment for the full 7 months prior to
             the screening phase.

          -  Subjects who have shown response to previous antipsychotic treatment.

          -  Subjects who understand the nature of the trial and are able to follow the protocol
             requirements.

        Exclusion Criteria:

          -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or
             have been incarcerated in the past 7 months for any reason must not be enrolled into
             this trial.

          -  Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during
             the trial.

          -  Any subject who requires or may need any other antipsychotic medications during the
             course of the trial, other than allowed rescue medication.

          -  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 deemed intolerant of receiving injectable treatment.

          -  Subjects who have received electroconvulsive therapy within the last 7 months prior to
             screening.

          -  Subjects with a history of neuroleptic malignant syndrome or clinically significant
             tardive dyskinesia as assessed by the investigator.

          -  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 requiring hospitalization for any psychiatric reason during the 4 weeks prior
             to signing the ICF or during the screening period.

          -  Subjects without at least 1 inpatient psychiatric hospitalization in the last 4 years
             (48 months) prior to screening.

          -  Subjects who have met DSM-IV-TR criteria for any significant substance use disorder
             within 3 months prior to screening.

          -  Subjects who are considered treatment-resistant to antipsychotic medication other than
             clozapine.

          -  Treatment with long-acting injectable antipsychotics in which the last dose was within
             7 months prior to screening.

          -  Subjects who have not been treated with oral antipsychotics for 7 months prior to
             screening.

          -  Subjects who have a significant risk of committing suicide

          -  Subjects who have a history or evidence of a medical condition that would expose them
             to an undue risk of a significant adverse event or interfere with assessments of
             safety or efficacy during the course of the trial.

          -  Females who are pregnant or lactating, sexually active males and females who will not
             commit to utilizing birth control during the trial and for up to 180 days following
             the trial.

          -  Abnormal laboratory or physical examination results indicating a condition which may
             interfere with the results of the study or pose a safety risk to the subject.

          -  Subjects who have previously enrolled in an aripiprazole IM depot clinical study,
             except for subjects entering this trial from the Canadian 31-11-284 trial.

          -  Subjects who have participated in any clinical trial with an investigational agent
             within the past 30 days.