Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole; Aripiprazole
Intervention description: Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg); Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 252.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Adolescent; Schizophrenia

Summary:

      This will be a randomized, double-blind, placebo-controlled study consisting of a screening
      period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind
      maintenance treatment phase (Phase 3), and a follow up period.

      Subjects may be either outpatients or inpatients between screening and through the time they
      reach stabilization at the end of Phase 2; hospitalization is not a study requirement.
      However, eligible subjects must be outpatients at the beginning of Phase 3.

      Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and
      3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be
      encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any
      tolerability issues. The investigator will also have the option to phone the subjects and
      their guardian(s) at any time to ensure clinical stability.

      A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing
      the interim analysis. One interim analysis is planned after 75% of the total expected number
      of impending relapse events (28 events) are achieved and will be conducted by an independent
      data analysis center. The DMC will make a recommendation about stopping or continuing the
      study based on safety and efficacy reviews. The results of the interim analysis and
      individual subject data will remain blinded to the sponsor during the course of the study
      until the DMC determines that the study will conclude based on the results of the interim
      analysis, or the study is completed after 37 endpoint events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a current DSM-IV-TR diagnosis of schizophrenia, and a history of the
             illness (diagnosis or symptoms) for at least 6 months prior to screening.

          -  Subjects who have shown previous response to antipsychotic treatment (other than
             clozapine) and are not resistant to treatment with other antipsychotics.

          -  Subjects who are currently being treated with oral or depot antipsychotics other than
             clozapine.

          -  Subjects with a history of relapse and/or exacerbation of symptoms when they are not
             receiving antipsychotic treatment.

        Exclusion Criteria:

          -  Subjects with a current DSM-IV-TR diagnosis other than schizophrenia.

          -  Subjects with delirium, dementia, amnesia or other cognitive disorders; subjects with
             psychotic symptoms that are better accounted for by another general medical
             condition(s) or direct effect of a substance (i.e., medication, illicit drug use,
             etc.).

          -  Subjects with attention deficit disorder or attention deficit hyperactivity disorder
             and/or subjects who were on a stimulant treatment for any period of time over the last
             one year prior to screening.

          -  Subjects with any neurodevelopmental disorder, except Tourette's syndrome.

          -  Subjects experiencing acute depressive symptoms within the past 30 days prior to
             screening.

          -  Subjects who meet the DSM-IV-TR criteria for substance dependence (including alcohol
             and benzodiazepines, but excluding caffeine and nicotine) within the past 180 days
             prior to screening.

          -  Subjects who have epilepsy, a history of seizures (except for a single childhood
             febrile seizure or post-traumatic seizure), or a history of severe head trauma or
             stroke, or have a history or current evidence of other unstable medical conditions.

          -  Subjects with a history of subclinical hypothyroidism (TSH ≥ 4.0 mIU/L), known
             hypothyroidism or hyperthyroidism (unless the condition has been stabilized with
             medication for at least 90 days prior to entry into Phase 1 or Phase 2).

          -  Subjects who have a medical history of uncontrolled diabetes, labile or unstable
             diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant
             abnormal blood glucose levels.