A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aripiprazole<br>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 | Drug: Aripiprazole<br> <br> * Other names: Abilify;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score | 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. | Basline and Week52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score | The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition. | Basline and Week52 | 
| Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS) | The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition. | Baseline and Week52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Pediatric patients