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Study to Evaluate the Efficacy and Safety of Aripiprazole

Primary Purpose

Autism

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
Yoo-Sook Joung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Aripiprazole, Abilify

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inje University Ilsan Paik HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Asan Medical Center
  • Medical City
  • Philippine Children's Medical Center
  • Siriraj Hospital Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aripiprazole

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech
ABC Scale will be completed by subject
Change of CGI-S, CGI-I from baseline
CGI-S, CGI-I scale will be evaluated by investigator
Change of Behavioral problems from baseline
Behavioral problems scale: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Change of Adaptive Skills from baseline
Adaptive Skills Scale: Vineland Adaptive Behavior Scale (VABS)
Change of Parental stress from baseline
Parental stress scale: Parenting Stress Index (PSI)

Full Information

First Posted
February 13, 2014
Last Updated
March 10, 2014
Sponsor
Yoo-Sook Joung
Collaborators
Korea Otsuka International Asia Arab
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1. Study Identification

Unique Protocol Identification Number
NCT02069977
Brief Title
Study to Evaluate the Efficacy and Safety of Aripiprazole
Official Title
A Multinational, Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Aripiprazole in Asian Pediatric Patients With Autism Spectrum Disorder and Behavior Problems
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yoo-Sook Joung
Collaborators
Korea Otsuka International Asia Arab

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autism, Aripiprazole, Abilify

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify®
Primary Outcome Measure Information:
Title
irritability subscale of the aberrant behavior checklist
Description
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
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech
Description
ABC Scale will be completed by subject
Time Frame
Week 1, 2, 4, 8, 12, 24, 36, 52
Title
Change of CGI-S, CGI-I from baseline
Description
CGI-S, CGI-I scale will be evaluated by investigator
Time Frame
Week 1, 2, 4, 8, 12, 24, 36, 52
Title
Change of Behavioral problems from baseline
Description
Behavioral problems scale: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Time Frame
Week 12, 52
Title
Change of Adaptive Skills from baseline
Description
Adaptive Skills Scale: Vineland Adaptive Behavior Scale (VABS)
Time Frame
week 12, 52
Title
Change of Parental stress from baseline
Description
Parental stress scale: Parenting Stress Index (PSI)
Time Frame
Weekk 12, 52
Other Pre-specified Outcome Measures:
Title
Adverse events (AEs)
Description
Safety will be evaluated based on below inormaiton. Laboratory test results (routine lab. and serum prolactin) Vital signs (blood pressure, pulse, body temperature) ECG Weight gain Extrapyramidal side effects (EPSEs) assessed by Simpson-Angus Rating Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS)
Time Frame
Week 1, 2, 4, 8, 12, 24, 36, 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyemi Cheon
Phone
82-70-4033-3059
Email
cheon.hyemi@cnrres.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoo-Sook Joung, MD. PhD.
Organizational Affiliation
Sumsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
State/Province
Gyeonggi-do
ZIP/Postal Code
411-706
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Jin Park, MD, PhD.
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoo-Sook Joung, MD., PhD.
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo-Won Kim, MD,PhD
Facility Name
Medical City
City
Pasig
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stella Manalo, MD
Facility Name
Philippine Children's Medical Center
City
Quezon City
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Reyes, MD
Facility Name
Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vitharon Boon-yasidhi, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
36112116
Citation
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.
Results Reference
derived

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Study to Evaluate the Efficacy and Safety of Aripiprazole

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