A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

Otsuka

Status and phase: Completed; Phase 3; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole Mid (6 - 12 mg/day); Drug: Aripiprazole Low (2 mg/day); Drug: Aripiprazole High (24 - 30 mg/day)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01942161

JapicCTI-101146 (Other Identifier)

031-09-003

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 3 patient groups

Low (2 mg/day)

Experimental group

Description:

Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).

Treatment:

Drug: Aripiprazole Low (2 mg/day)

Mid (6 - 12 mg/day)

Experimental group

Description:

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.

Treatment:

Drug: Aripiprazole Mid (6 - 12 mg/day)

High (24 - 30 mg/day)

Experimental group

Description:

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.

Treatment:

Drug: Aripiprazole High (24 - 30 mg/day)