Study to Evaluate the Efficacy and Safety of Aripiprazole

NCT ID: NCT02069977

Last Updated: 2014-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-02-29

Brief Summary

• To evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder, as measured by change from baseline to endpoint on the irritability subscale of the aberrant behavior checklist (ABC-I).
• To evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the treatment of serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder.

Detailed Description

1. Study design

• Multi-national, Multi-center, 52 weeks open label, single arm design

Conditions

Autism

Study Design

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

Study Groups

Aripiprazole

• Dose level: 2, 5, 10, 15 mg/day
• Starting dose: 2 mg/day
• Dose increment: The dose should be gradually increased according to the investigator's judgment of subject's response.
• Target dose: 5-15 mg/day
• Maximum dose: 15 mg/day
• Flexibly dosed (2 to 15 mg/day) aripiprazole (oral tablet or solution) is taken once in a day at the same time without regarding to meals

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Interventions

Aripiprazole

Intervention Type: DRUG

Other Intervention Names

Abilify®

Eligibility Criteria

Inclusion Criteria

• 6 to 17 years of age.
• Meeting the diagnostic criteria for autistic disorder specified by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), with a diagnosis corroborated by the Autism Diagnostic Interview-Revised (ADI-R) diagnostic instrument and demonstrated behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these.
• Clinical Global Impressions (CGI) Severity subscale score ≥ 4 at screening and baseline.
• Aberrant Behavior Checklist (ABC) Irritability subscale score ≥18 at screening and baseline.
• Mental age ≥ 18 months.
• Women of childbearing potential (WOCBP) have to use an adequate method of contraception
• WOCBP must have had a negative serum or urine pregnancy test.
• The patient and/or the designated guardian(s) or caregiver(s) who are able to comprehend and comply with the protocol requirements, in the opinion of the investigator and have consented to participate by signing an informed consent form.

Exclusion Criteria

• Current diagnosis of bipolar disorder, schizophrenia, major depressive disorder, Rett's disorder, or Fragile-X syndrome.
• History of neuroleptic malignant syndrome.
• Significant risk of committing suicide based on history or routine psychiatric status examination.
• History of seizure in the past 1 year.
• History of severe head trauma or stroke
• History or current evidence of any unstable medical conditions
• Patient considered treatment resistant to neuroleptic medication
• Patient considered treatment resistant to aripiprazole
• Woman who is pregnant or breastfeeding
• ECG: QTc > 475 msec
• Platelets ≤ 75,000/μL
• Hemoglobin ≤ 9 g/dL
• Neutrophils ≤ 1.0x10^3/μL
• Aspartate or alanine transaminase (AST or ALT) > 3xULN
• Serum creatinine ≥ 2 mg/dL
• Patient weighed < 15 kg
• Patient who participated in any other clinical trial within 4 weeks
• Patient determined to require the administration of the prohibited medications during the study period
• Patient with other conditions determined by the investigator to be inappropriate for this clinical study

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Otsuka International Asia Arab

INDUSTRY

Sponsor Role: collaborator

Yoo-Sook Joung

OTHER

Sponsor Role: lead

Responsible Party

Yoo-Sook Joung

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yoo-Sook Joung, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Sumsung Medical Center

Locations

Medical City

Pasig, , Philippines

Site Status: NOT_YET_RECRUITING

Philippine Children's Medical Center

Quezon City, , Philippines

Site Status: NOT_YET_RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, Gyeonggi-do, South Korea

Site Status: RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status: NOT_YET_RECRUITING

Siriraj Hospital Mahidol University

Bangkok, , Thailand

Site Status: NOT_YET_RECRUITING

Countries

Philippines; South Korea; Thailand

Central Contacts

Hyemi Cheon

Role: CONTACT

cheon.hyemi@cnrres.co.kr

82-70-4033-3059

References

Kim BU, Kim HW, Park EJ, Kim JH, Boon-Yasidhi V, Tarugsa J, Reyes A, Manalo SG, Joung YS. Long-Term Improvement and Safety of Aripiprazole for Irritability and Adaptive Function in Asian Children and Adolescents with Autistic Disorder: A 52-Week, Multinational, Multicenter, Open-Label Study. J Child Adolesc Psychopharmacol. 2022 Sep;32(7):390-399. doi: 10.1089/cap.2022.0004.

Reference Type: DERIVED

PMID: 36112116 (View on PubMed)

Other Identifiers

031OTC1301

Identifier Type: -

Identifier Source: org_study_id