Clinical trial NCT01942148: A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia, Pediatric patients
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-09-13
Enrollment: 68
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Basline and Week52
Secondary outcomes:
measure: Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score
timeFrame: Basline and Week52
measure: Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)
timeFrame: Baseline and Week52
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Hokkaido Region
country: Japan
city: Kansai Region
country: Japan
city: Kanto Region
country: Japan
city: Kyushu Region
country: Japan
city: Shikoku Region
country: Japan
city: Tohoku Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Kyoji Imaoka, Mr
role: STUDY_DIRECTOR
References: