AutismPhase 4NCT02069977
Study to Evaluate the Efficacy and Safety of Aripiprazole
A Phase 4 study testing Aripiprazole in people with Autism, run by Yoo-Sook Joung at 6 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Autism
- What is being tested?
- Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Feb 2014to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
South Korea3 sites, 3 recruiting
- Recruiting
Inje University Ilsan Paik Hospital
Ilsan, Gyeonggi-do, 411-706
Eun-Jin Park, MD, PhD.
- Recruiting
Samsung Medical Center
Seoul, 135-710
Yoo-Sook Joung, MD., PhD.
- Not yet recruiting
Asan Medical Center
Seoul, 138-736
Hyo-Won Kim, MD,PhD
Philippines2 sites, 2 recruiting
- Not yet recruiting
Medical City
Pasig
Stella Manalo, MD
- Not yet recruiting
Philippine Children's Medical Center
Quezon City
Alexis Reyes, MD
Thailand1 site, 1 recruiting
- Not yet recruiting
Siriraj Hospital Mahidol University
Bangkok, 10700
Vitharon Boon-yasidhi, MD
About this study
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
- 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.
Read the detailed description
- Study design
- Multi-national, Multi-center, 52 weeks open label, single arm design
- Conditions
- Autism
- Being tested
- Aripiprazole
- Keywords
- Autism, Aripiprazole, Abilify
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify®
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Secondary outcomes (5)
Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech
ABC Scale will be completed by subject
Measured: Week 1, 2, 4, 8, 12, 24, 36, 52
Change of CGI-S, CGI-I from baseline
CGI-S, CGI-I scale will be evaluated by investigator
Measured: Week 1, 2, 4, 8, 12, 24, 36, 52
Change of Behavioral problems from baseline
Behavioral problems scale: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Measured: Week 12, 52
Change of Adaptive Skills from baseline
Adaptive Skills Scale: Vineland Adaptive Behavior Scale (VABS)
Measured: week 12, 52
Change of Parental stress from baseline
Parental stress scale: Parenting Stress Index (PSI)
Measured: Weekk 12, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yoo-Sook Joung
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Otsuka International Asia Arab
- Responsible party
- Sponsor-investigator, Yoo-Sook Joung, Samsung Medical Center
- Investigators
- Yoo-Sook Joung, MD. PhD., Principal investigator, Sumsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069977
- Sponsor's protocol ID
- 031OTC1301
- Status last verified
- Mar 2014
- First submitted
- 13 Feb 2014
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36112116
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02069977
- Acronym / sponsor ID
- 031OTC1301
- Conditions
- Autism
- Keywords
- Autism, Aripiprazole, Abilify
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Yoo-Sook JoungUniversity, hospital or other
- Collaborators
- Korea Otsuka International Asia Arab
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- Study design
- Multi-national, Multi-center, 52 weeks open label, single arm design
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Experimental | Drug: 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 |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAlso: Abilify® | Drug | Aripiprazole |
Primary outcome
irritability subscale of the aberrant behavior checklist
Time frame: Week 12
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
5 secondary outcomes
Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 52
Change of CGI-S, CGI-I from baseline
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 52
Change of Behavioral problems from baseline
Time frame: Week 12, 52
Change of Adaptive Skills from baseline
Time frame: week 12, 52
Change of Parental stress from baseline
Time frame: Weekk 12, 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
- Derived from this study: PubMed 36112116Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoo-Sook Joung, MD. PhD. principal investigator
Sumsung Medical Center
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole in people with Autism, run by Yoo-Sook Joung at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea, Philippines, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyemi Cheon (82-70-4033-3059, cheon.hyemi@cnrres.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
irritability subscale of the aberrant behavior checklist (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02069977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.