A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Schizophrenia, Pediatric patients

Summary:

      The objective of this study is to investigate the safety and efficacy of aripiprazole
      (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally
      administered over a period of 52 weeks in subjects who complete a short-term treatment study
      of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60),
             according to DSM-IV-TR

          -  Male and female patients aged 13-17 years

          -  Patients completing the 031-09-003 study

          -  Patients who, in addition to their legal guardian, provide written informed consent,
             having understood the details of this study

          -  Inpatient or outpatient status

        Exclusion Criteria:

          -  Patients who have a diagnosis of any other disease except schizophrenia, according to
             DSM-IV-TR

          -  Patients who have been compulsorily admitted to hospital

          -  Patients with mental retardation

          -  Patients with thyroid disorder

          -  Patients who fall under a contraindication listed in the ABILIFY package insert

          -  Patients with a serious hepatic, renal, cardiac or hematopoietic disorder

          -  Patients with a history or a complication of organic brain disorder or convulsive
             disorder such as epilepsy

          -  Patients with a history or a complication of diabetes and patients who fall under any
             of the following: fasting blood glucose level ≧ 126 mg/dL, non-fasting blood glucose
             level ≧ 200 mg/dL, HbA1c ≧ 6.5%

          -  Patients with a history or a complication of suicide attempt, suicidal thought or
             self-harm

          -  Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS

          -  Patients with a history or a complication of malignant syndrome, tardive dyskinesia or
             paralytic ileus

          -  Patients in a state of physical exhaustion accompanied by such conditions as
             dehydration or malnutrition

          -  Patients with a history or a complication of water intoxication

          -  Patients with Parkinson's disease

          -  Pregnant women, parturient women, nursing women, women of childbearing potential who
             wish to become pregnant during this trial. However, women of childbearing potential
             who are practicing an appropriate method of contraception (refer to 8.6) and have a
             negative pregnancy test result are eligible for inclusion in this study.

          -  Study enrollment is otherwise judged to be inappropriate by the Investigator or
             Subinvestigator