Overview

This trial has been completed.

Condition schizophrenia
Treatment aripiprazole
Phase phase 3
Sponsor Otsuka Pharmaceutical Co., Ltd.
Start date August 2010
End date November 2015
Trial size 68 participants
Trial identifier NCT01942148, 031-09-004, JapicCTI-101147

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
aripiprazole Abilify

Primary Outcomes

Measure
Adverse events
time frame: Up to 52 weeks

Secondary Outcomes

Measure
Positive and Negative Syndrome Scale (PANSS)
time frame: Week1, Week2, Week4, Week8, Week12, Week16, Week24, week32, Week40, Week48, Week52
Clinical golobal impression (CGI)
time frame: Week1, Week2, Week4, Week8, Week12, Week16, Week24, week32, Week40, Week48, Week52
Children's Global Assessment Scale (CGAS)
time frame: Week24, Week52

Eligibility Criteria

Male or female participants from 13 years up to 17 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd..