Overview

This trial has been completed.

Condition schizophrenia
Treatments aripiprazole low (2 mg/day), aripiprazole mid (6 - 12 mg/day), aripiprazole high (24 - 30 mg/day)
Phase phase 2/phase 3
Sponsor Otsuka Pharmaceutical Co., Ltd.
Start date August 2010
End date November 2014
Trial size 106 participants
Trial identifier NCT01942161, 031-09-003, JapicCTI-101146

Summary

The objective of this study is to investigate the efficacy and safety of three different doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
aripiprazole low (2 mg/day) Aripiprazole
administered 2 mg once daily for 6 weeks
(Experimental)
Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
aripiprazole mid (6 - 12 mg/day) Aripiprazole
administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg
(Experimental)
Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
aripiprazole high (24 - 30 mg/day) Aripiprazole
administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg

Primary Outcomes

Measure
Positive and Negative Syndrome Scale (PANSS) total sore
time frame: baseline, Day 43

Secondary Outcomes

Measure
PANSS score
time frame: Screening, Day1, Day8, Day15, Day22, Day29, Day43
Clinical Global Impression (CGI)
time frame: Day1, Day8, Day15, Day22, Day29, Day43
Children's Global Assessment Scale (CGAS)
time frame: Day1, day43
Adverse events
time frame: up to Day 43
Electrocardiogram
time frame: Screening, Day43

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 (M.I.N.I.KID will be used as backup) - Male and female patients aged 13-17 years (between IC and end of dosing) - Patients with a PANSS score of 70 or more [both at start of dosing (Day 1 and at baseline - 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 have a history of receiving treatment with clozapine, or who have received sufficient doses of two or more kinds of antipsychotic drug for more than four weeks but failed to respond to this treatment - Patients who have received a prohibited concomitant medication or therapy listed in table 6.4-1 after the start of the prohibited concomitant medication timeframe [to be confirmed at start of dosing (Day 1) and at baseline]. - Patients who have a history of receiving treatment with aripiprazole - 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 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 and have a negative pregnancy test result are eligible for inclusion in this study. - Patients who have a diagnosis of a substance-related disorder according to DSM-Ⅳ-TR within the past 3 months - Patients with a positive drug screen (urine) result - Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator

Additional Information

Official title A Multicenter, Double-blind, Randomized, Dose-comparison Study of Three Different Doses of Aripiprazole (2 mg/Day, 6-12 mg/Day, 24-30 mg/Day) Orally Administered Over 6 Weeks in Pediatric Patients (Aged 13-17 Years) With Schizophrenia
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd..