Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.
Condition: Adolescent Schizophrenia; Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders; Bipolar Disorder
Intervention: Aripiprazole
Intervention description: Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 524.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: schizophrenia; adolescent; bipolar

Summary:

      This is an open-label study consisting of a screening period, a conversion/titration phase
      (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.

      The study will enroll new subjects (hereafter referred as "de novo" subjects) with
      schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic
      features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as
      "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who
      are screened and are not required to go through Phase 1 will complete a Phase 2 baseline
      visit prior to their participation in Phase 2.

      Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy
      Study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 13-17 years old (Schizophrenia); Subjects 10-17 years old (Bipolar manic or
             mixed episode)* [*Bulgaria will enroll Schizophrenia subjects only.]

          -  Subjects with a current diagnosis of schizophrenia, and a history of the illness
             (diagnosis or symptoms) for at least 6 months prior to screening (as per subject,
             family, or healthcare provider, or by previous medical records).

          -  Subjects with a current diagnosis of bipolar I disorder, manic or mixed episode with
             or without psychotic features (diagnosis or symptoms) experiencing symptoms for at
             least 1 week prior to screening. * [*These subjects will not be eligible to enroll in
             Bulgaria]

          -  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 antipsychotics other than
             clozapine, and are not resistant to treatment with other antipsychotics.

          -  Inpatient or outpatient status, with the exception of acute hospitalization due to
             psychiatric reasons at the time of screening or before Phase 2.

        Exclusion Criteria:

          -  All subjects: diagnosis of schizoaffective disorder, autism, pervasive developmental
             disorder (PDD), OCD, or PTSD.

          -  Subjects with schizophrenia: a current major depressive episode.

          -  Subjects with bipolar manic or mixed episode: presenting with a clinical picture
             and/or history that is consistent with a diagnosis of bipolar II disorder or bipolar
             disorder not otherwise specified.

          -  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 any neurological disorder, with the exception of Tourette's syndrome.

          -  Subjects experiencing major depressive episode at the time of screening other than
             subjects diagnosed with bipolar I disorder mixed episode.

          -  Subjects who are currently receiving clozapine or have received clozapine at any time
             in the past are ineligible for entry into the study.

          -  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
             medications 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 (defined as fasting blood glucose ≥ 125 mg/dL).