AutismNCT03179787

Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

An observational study of Autism, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan. 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 oral product
Type of treatment: Pill or oral medicine
How many people: 528 participants
Where: 1 siteJapan
Study dates: 1 Apr 2017to 6 Jul 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: naive patients with aripiprasole

Who may be able to join

diagnosed as autism with irritability

Who cannot join

patients who has ever been treated with aripiprazole

Trial locations and contacts

1 site in 1 country.

Japan1 site

Otsuka Pharmaceutical Co., Ltd.
Tokyo

Other trials in Japan

About this study

The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.

Conditions: Autism
Being tested: Aripiprazole oral product
Medical subject headings: Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aripiprazole oral productDrug
oral administration of aripiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline.
Using caregiver-rated ABC-J, the degree of aberrant behaviors was scored on four levels ranging from 0 'not at all a problem', 1 'slight problem', 2 'moderately serious problem' to 3 'the problem is severe in degree' in irritability subscale (including 15 items describing symptoms of irritability, such as temper tantrums, aggression, mood changes, and self-injury).
The irritability subscale score ranging from 0 to 45 was derived from the sum of the 15 items and higher values represent a worse outcome.
Measured: Baseline, Week 4, 8, 16, 24, 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20176 Jul 2020

First posted7 Jun 2017
Study start1 Apr 2017
Primary completion17 Mar 2020
Study completion6 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AutismStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 528 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03179787
Sponsor's protocol ID: 031-101-00116
Status last verified: Aug 2021
First submitted: 1 Jun 2017
Last updated: 16 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Sugimoto Y, Yamamura K, Takayama T, Fukuta Y, Aoki K, Mikami K, Tomoda A. Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance. BMC Psychiatry. 2021 Apr 22;21(1):204. doi: 10.1186/s12888-021-03201-6.
PubMed 33888067

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
ClinicalTrials.gov ID: NCT03179787
Acronym / sponsor ID: 031-101-00116
Conditions: Autism
Study type: Observational
Recruitment status: Completed
Enrolment: 528 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Apr 2017 (actual)
Primary completion: 17 Mar 2020 (actual)
Study completion: 6 Jul 2020 (actual)
First posted: 7 Jun 2017 (actual)
Results: Posted 16 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: naive patients with aripiprasole

Key inclusion criteria (1 listed)

diagnosed as autism with irritability

Key exclusion criteria (1 listed)

patients who has ever been treated with aripiprazole

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
Aripiprazole oral productoral administration of aripiprazole	Drug	–

Primary outcome

Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline.
Time frame: Baseline, Week 4, 8, 16, 24, 52
Using caregiver-rated ABC-J, the degree of aberrant behaviors was scored on four levels ranging from 0 'not at all a problem', 1 'slight problem', 2 'moderately serious problem' to 3 'the problem is severe in degree' in irritability subscale (including 15 items describing symptoms of irritability, such as temper tantrums, aggression, mood changes, and self-injury). The irritability subscale score ranging from 0 to 45 was derived from the sum of the 15 items and higher values represent a worse outcome.

Results and safety

Results posted to the registry on 16 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Safety Analysis Group	528	510

Primary outcome: Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline.

Time frame: Baseline, Week 4, 8, 16, 24, 52. Mean (Standard Deviation). Unit: score on a scale

Measure	Safety Analysis Group n = 396
Baseline	19.8 (9.5)
Week 4	14.7 (8.8)
Week 8	12.9 (8.1)
Week 16	12.7 (8.3)
Week 24	13.4 (8.9)
Week 52	13.1 (9.1)
End-point (LOCF)	13.0 (9.0)

Population analysed: Twenty-one patients with the protocol deviations (including all effectiveness measures were not assessed after treatment: n = 11, all effectiveness measures were assessed over 7 days after last dose: n = 7, the daily dose was \> 15 mg: n = 2, all effectiveness were assessed after day 393: n = 1) were excluded, and then efficacy sample consisted of all participants who have Baseline and at least one Post-Baseline effectiveness evaluation.

Adverse events

Time frame: Adverse events were observed from first dose until follow-up for 52 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Analysis Group	3 of 510 (0.6%)	82 of 510 (16.1%)	0 of 510

Limitations and caveats (from the sponsor): It was an observational study in daily clinical practice without a comparison group. In addition, there were deficiencies in the assessments and variations in the reports and evaluation based on the reporting made by the physicians and caregivers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33888067Sugimoto Y, Yamamura K, Takayama T, Fukuta Y, Aoki K, Mikami K, Tomoda A. Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance. BMC Psychiatry. 2021 Apr 22;21(1):204. doi: 10.1186/s12888-021-03201-6.

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RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
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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.

Pharmacovigilance study director

Otsuka Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Autism, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. (time frame: Baseline, Week 4, 8, 16, 24, 52). 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 NCT03179787, 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 16 Sep 2021.