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

Schizophrenia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942148
• Other study ID #: 031-09-004
• Secondary ID: JapicCTI-101147
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2013
• Last updated: October 24, 2016
• Start date: August 2010
• Est. completion date: November 2015

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• 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-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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole

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	Adverse events		Up to 52 weeks	Yes
Secondary	Positive and Negative Syndrome Scale (PANSS)		Week1, Week2, Week4, Week8, Week12, Week16, Week24, week32, Week40, Week48, Week52	No
Secondary	Clinical golobal impression (CGI)		Week1, Week2, Week4, Week8, Week12, Week16, Week24, week32, Week40, Week48, Week52	No
Secondary	Children's Global Assessment Scale (CGAS)		Week24, Week52	No