A Multicenter, Open-label, Long-term Safety Study of Aripiprazole (Initial Dose 2 mg/Day, Maintenance Dose 6-24 mg/Day, Maximum Dose 30 mg/Day) Orally Administered Over 52 Weeks in Patients Who Complete a Short-term Treatment Study of Aripiprazole in Pediatric Patients (Aged 13-17 Years) With Schizophrenia (031-09-003 Study)
Overview
- Phase
- Phase 3
- Intervention
- Aripiprazole
- Conditions
- Schizophrenia
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Enrollment
- 68
- Primary Endpoint
- Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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).
Investigators
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
Arms & Interventions
Aripiprazole
Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study
Intervention: Aripiprazole
Outcomes
Primary Outcomes
Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Basline and Week52
The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.
Secondary Outcomes
- Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score(Basline and Week52)
- Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)(Baseline and Week52)