A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

NCT ID: NCT01942148

Last Updated: 2017-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2015-11-30

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).

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole

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

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Interventions

Aripiprazole

Intervention Type: DRUG

Other Intervention Names

Abilify

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyoji Imaoka, Mr

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Chubu Region, , Japan

Chugoku Region, , Japan

Hokkaido Region, , Japan

Kansai Region, , Japan

Kanto Region, , Japan

Kyushu Region, , Japan

Shikoku Region, , Japan

Tohoku Region, , Japan

Countries

Japan

Other Identifiers

JapicCTI-101147

Identifier Type: OTHER

Identifier Source: secondary_id

031-09-004

Identifier Type: -

Identifier Source: org_study_id