A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942161
• Other study ID #: 031-09-003
• Secondary ID: JapicCTI-101146
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 10, 2013
• Last updated: October 24, 2016
• Start date: August 2010
• Est. completion date: November 2014

Study information

• Verified date: October 2016
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-?-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-?-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole Low (2 mg/day)
administered 2 mg once daily for 6 weeks
• Aripiprazole Mid (6 - 12 mg/day)
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
• Aripiprazole High (24 - 30 mg/day)
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS) total sore	Change from baseline to final evaluation	baseline, Day 43	No
Secondary	PANSS score		Screening, Day1, Day8, Day15, Day22, Day29, Day43	No
Secondary	Clinical Global Impression (CGI)		Day1, Day8, Day15, Day22, Day29, Day43	No
Secondary	Children's Global Assessment Scale (CGAS)		Day1, day43	No
Secondary	Adverse events		up to Day 43	Yes
Secondary	Electrocardiogram		Screening, Day43	Yes