Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole depot 300 or 400 mg; Aripiprazole 10-30 mg orally; Aripiprazole depot 25 or 50 mg; Placebo depot; Placebo tablets
Intervention description: Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg.; Aripiprazole was supplied as 10, 15, and 20 mg tablets. The dose that the patient received was based on the investigator's judgment and the subject's clinical need.; Aripiprazole depot was supplied in 200 mg lyophilized vials. Patients received aripiprazole 25 mg if they were unable to tolerate aripiprazole 50 mg.; Placebo depot was supplied in lyophilized vials.; Placebo tablets were identical in appearance to the aripiprazole tablets.
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 937.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Aripiprazole; Intramuscular (IM) depot; Schizophrenia

Summary:

      The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an
      intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients
      with schizophrenia

      The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject
      to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole
      monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be
      stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in
      Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are
      eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During
      Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending
      relapse for up to 38 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are able to provide written informed consent and/or consent obtained from
             a legally acceptable representative (as required by Institutional Review
             Board/Independent Ethics Committee [IRB/IEC]), prior to the initiation of any
             protocol-required procedures.

          -  Male and female subjects 18 to 60 years of age, inclusive, at time of informed
             consent.

          -  Subjects with a current diagnosis of schizophrenia as defined by Diagnostic and
             Statistical Manual of Mental Disorders, version 4, Text Revision (DSM-IV-TR) criteria
             and a history of the illness for at least 3 years prior to screening.

          -  Subjects who, in the investigator's judgment, require chronic treatment with an
             anti-psychotic 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 outcome 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 2 positive drug
             screens for cocaine.

          -  Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment
             with aripiprazole or other quinolinones, or hypersensitivity to anti-psychotic agents,
             including aripiprazole.

          -  Subjects with a history of neuroleptic malignant syndrome or clinically significant
             tardive dyskinesia at screening.

          -  Subjects with uncontrolled thyroid function abnormalities.

          -  Subjects with a history of seizures, neuroleptic malignant syndrome, clinically
             significant tardive dyskinesia, or other medical condition that would expose the
             subject to undue risk or interfere with study assessments.

          -  Subjects who are involuntarily incarcerated.

          -  Subjects who have undergone electroconvulsive therapy within 180 days of entry into
             Phase 2.

          -  Subjects who have used an investigational agent within 30 days of screening; and prior
             participation in a clinical study with aripiprazole IM depot.

          -  Subjects with clinically significant abnormalities in laboratory test results, vital
             signs, or ECG results.

          -  Subjects hospitalized for more than 30 days in the 90 days prior to Phase 1 (or Phase
             2 for subjects bypassing Phase 1).

          -  Subjects requiring more than 1 benzodiazepine beyond screening (eg, lorazepam and
             oxazepam).

          -  Subjects who fail to wash-out from prohibited concomitant medications, including the
             use of CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers, antipsychotics, antidepressants
             (including monoamine oxidase inhibitors [MAOI]), and mood stabilizers, during
             screening and Phase 1.