NCT02069977

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
79

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2014

Geographic Reach
3 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

2 years

First QC Date

February 13, 2014

Last Update Submit

March 10, 2014

Conditions

Autism

Keywords

AutismAripiprazoleAbilify

Outcome Measures

Primary Outcomes (1)

  • irritability subscale of the aberrant behavior checklist

    Mean change from baseline to endpoint of Part 1 (week 12)in the caregiver-rated ABC Irritability (ABC-I) subscale score. ABC Scale will be completed by subject

    Week 12

Secondary Outcomes (5)

  • Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech

    Week 1, 2, 4, 8, 12, 24, 36, 52

  • Change of CGI-S, CGI-I from baseline

    Week 1, 2, 4, 8, 12, 24, 36, 52

  • Change of Behavioral problems from baseline

    Week 12, 52

  • Change of Adaptive Skills from baseline

    week 12, 52

  • Change of Parental stress from baseline

    Weekk 12, 52

Other Outcomes (1)

  • Adverse events (AEs)

    Week 1, 2, 4, 8, 12, 24, 36, 52

Study Arms (1)

Aripiprazole

EXPERIMENTAL

* 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

Drug: Aripiprazole

Interventions

AripiprazoleDRUG
Also known as: Abilify®
Aripiprazole

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medical City

Pasig, Philippines

NOT YET RECRUITING

Philippine Children's Medical Center

Quezon City, Philippines

NOT YET RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, Gyeonggi-do, 411-706, South Korea

RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Asan Medical Center

Seoul, 138-736, South Korea

NOT YET RECRUITING

Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 36112116DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Yoo-Sook Joung, MD. PhD.

    Sumsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyemi Cheon

CONTACT

82-70-4033-3059cheon.hyemi@cnrres.co.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 24, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations

PH(2)KR(3)TH(1)