AutismAbilifyNCT00468130

Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children

A study testing Aripiprazole in people with Autism, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

Completed

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

Official record

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Trial summary

Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale. (2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity. Read more about this study

Who is it for?: Ages 5 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?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteUnited States
Study dates: May 2006to Nov 2009
Phase: Interventional
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 5 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Meets DSM-IV, ADI-R criteria for autistic disorder.
Age 5-17 years.
Outpatients
Parent or legal guardian willing to sign informed consent.

Who cannot join

Subject has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
Subject has caused visible harm to him/herself.
Subject has an active seizure disorder or epilepsy (seizures within the past year).
Subject has an unstable medical illness, including heart disease.
Subject has experienced brain injury.
Subject has a history of diabetes.

Show all 10Show fewer

Subject reports significant improvement of autism symptoms and behaviors to current medication or other therapies.
Subject has a history of prior treatment with Aripiprazole of 5 mg/day or higher for 6 weeks.
Subject lives in a far away area and/or does not have regular access to transportation to the clinical facility.
Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.

Trial locations and contacts

1 site in 1 country.

United States1 site

Department of Child and Adolescent Psychiatry, University Behavioral Health Care Building
Piscataway, New Jersey, 08854

Other trials in United States

About this study

(2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity.

The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.

Read the detailed description

Aripiprazole is an atypical antipsychotic medication which is currently approved for the treatment of schizophrenia in adults. Multiple clinical trials in both children and adults have shown the effectiveness in the treatment of autism with medications like Aripiprazole. This study aims at assessing the effect of aripiprazole vs. placebo treatment on symptoms of irritability and aggression associated with autism, as well as the effect on the global severity of child and adolescent autistic disorder. Children or adolescent outpatients, with age ranges from 5-17, will be enrolled into an 8-week placebo controlled, double blind treatment study. During the 8 weeks, patients will be monitored by the treating psychiatrist. Study assessments will be administered at designated time points.

Conditions: Autism
Being tested: Aripiprazole, Placebos
Keywords: Aggression, Irritability, Global autism severity
Medical subject headings: Autistic Disorder, Aggression

What participants receive

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

AripiprazoleDrug
Also called Abilify
Subjects under 40 kg will be started on 2.5mg per day of aripiprazole for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects
PlacebosDrug
Also called Placebo
Inactive tablet made to resemble active tablet
Subjects under 40 kg will be started on 2.5mg per day of placebo for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects

Study groups in NCT00468130
Study group	Role	What they receive
Aripiprazole	Experimental	Subjects in the experimental group will receive Aripiprazole Receives: Drug: Aripiprazole
Placebo	Placebo comparator	Subjects in the control group will receive sugar pill Receives: Drug: Placebos

What is being measured

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

Clinical Global Impression Improvement (CGI-AD)
Clinical Global Impression Improvement (CGI)-AD (Guy, 1976). This is a standard rating scale with 7-point global severity and change scales which has been modified for Autistic Disorder. A rating of 2 is given when there is a substantial reduction in symptoms so that a treating clinician would be unlikely to change treatment. A rating of 1 is reserved for patients who become virtually symptom-free. A rating of 3 (minimally improved) on the CGI is defined as slight symptomatic improvement that is not deemed clinically significant. Administration time is approximately 2 minutes. Minimum is 1 and maximum is 5. A lower score indicates improvement, whereas a higher score indicates worsening.
Measured: Administered weekly, initial and week 8 reported

Secondary outcomes (1)

Aberrant Behavior Checklist
Aberrant Behavior Checklist (ABC) (irritability section) (Aman et al, 1985). The Aberrant Behavior Checklist assesses drug and other treatment effects on mentally retarded individuals. It consists of a five-factor scale comprising 58 items. We will use the Irritability section to assess aggressive and agitated behavior. While the internal consistency, validity and test-retest reliability were reported to be very good, inter-rater reliability was moderate (Aman et al, 1985). The ABC will be filled out by an informant, and then reviewed by the psychiatrist. Administration time is approximately 10 minutes. Maximum is 36, minimum is 0, a lower score indicates improvement.
Measured: Administered biweekly, initial and week 8 reported

Timeline

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

May 2006Nov 2009

First posted2 May 2007 (estimated)
Study startMay 2006
Primary completionNov 2009
Study completionNov 2009

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 (2)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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00468130
Sponsor's protocol ID: 0220055441
Acronym: Abilify
Status last verified: Dec 2021
First submitted: 30 Apr 2007
Last updated: 14 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: No plan at this time.

Publications

Aman M, Smgh N, Stewart A, Field C. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects.Am J Ment Defic, 1985a;89(5):485 491 Campbell M, et al, Neuroleptic related dyskinesias in autistic children: a prospective longitudinal study, J Am Acad Child Adolesc Psychiatry 1997; 36(6): 835 43. Fomboime E. The epidemiology of autism: a review. Psychological Medicine, 1999; 29:769 786. Guy W. ECDEU assessment manual for psychopharmacology. Revised. NTMH Publication DHEW Publ No (adm.) 76 388. Bethesda, MD: National Institute of Mental Health, 1976; 217 222. McDougle CJ, Holmes JP, Bronson MR, Anderson GM, Volkmar FR, Price LH, Cohen DJ. Risperidone treatment of children and adolescents with pervasive developmental disorders: a prospective open label study. J Am Acad Child Adolesc Psychiatry. 1997 May;36(5):685 93. Stahl SM. Dopamine system stabilizers, aripiprazole, and the next generation of antipsychotics, J Clin Psychiatry. 2001;62(l1).
Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
PubMed 37811711

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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children
ClinicalTrials.gov ID: NCT00468130
Acronym / sponsor ID: Abilify / 0220055441
Conditions: Autism
Keywords: Aggression, Irritability, Global autism severity
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of Medicine and Dentistry of New JerseyUniversity, hospital or other
Study start: May 2006
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 2 May 2007 (estimated)
Results: Posted 14 Jan 2022

Clinical summary

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

(2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity.

The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aripiprazole	Experimental	Drug: AripiprazoleSubjects in the experimental group will receive Aripiprazole
Placebo	Placebo comparator	Drug: PlacebosSubjects in the control group will receive sugar pill

Who may qualify

Ages: 5 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Meets DSM-IV, ADI-R criteria for autistic disorder.
Age 5-17 years.
Outpatients
Parent or legal guardian willing to sign informed consent.

Key exclusion criteria (10 listed)

Subject has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
Subject has caused visible harm to him/herself.
Subject has an active seizure disorder or epilepsy (seizures within the past year).
Subject has an unstable medical illness, including heart disease.
Subject has experienced brain injury.

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: AbilifySubjects under 40 kg will be started on 2.5mg per day of aripiprazole for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects	Drug	Aripiprazole
PlacebosAlso: PlaceboInactive tablet made to resemble active tablet Subjects under 40 kg will be started on 2.5mg per day of placebo for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects	Drug	Placebo

Primary outcome

Clinical Global Impression Improvement (CGI-AD)
Time frame: Administered weekly, initial and week 8 reported
Clinical Global Impression Improvement (CGI)-AD (Guy, 1976). This is a standard rating scale with 7-point global severity and change scales which has been modified for Autistic Disorder. A rating of 2 is given when there is a substantial reduction in symptoms so that a treating clinician would be unlikely to change treatment. A rating of 1 is reserved for patients who become virtually symptom-free. A rating of 3 (minimally improved) on the CGI is defined as slight symptomatic improvement that is not deemed clinically significant. Administration time is approximately 2 minutes. Minimum is 1 and maximum is 5. A lower score indicates improvement, whereas a higher score indicates worsening.

1 secondary outcome

Aberrant Behavior Checklist
Time frame: Administered biweekly, initial and week 8 reported

Results and safety

Results posted to the registry on 14 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole	7	5
Placebo	6	4

Primary outcome: Clinical Global Impression Improvement (CGI-AD)

Time frame: Administered weekly, initial and week 8 reported. Mean (Standard Deviation). Unit: score on a scale

Measure	Aripiprazole n = 7	Placebo n = 6
Initial CGI score	3.83 (0.41)	4.25 (1.25)
Week 8 CGI score	2.67 (1.21)	4.25 (1.5)

Population analysed: Participants were children with autism who enrolled in the study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected during the period of the active study. Adverse events for each participant were collected during that participants enrollment in the study, initial contact through end of study, an average of 12 weeks for each participant.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Placebo	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundAman M, Smgh N, Stewart A, Field C. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects.Am J Ment Defic, 1985a;89(5):485 491 Campbell M, et al, Neuroleptic related dyskinesias in autistic children: a prospective longitudinal study, J Am Acad Child Adolesc Psychiatry 1997; 36(6): 835 43. Fomboime E. The epidemiology of autism: a review. Psychological Medicine, 1999; 29:769 786. Guy W. ECDEU assessment manual for psychopharmacology. Revised. NTMH Publication DHEW Publ No (adm.) 76 388. Bethesda, MD: National Institute of Mental Health, 1976; 217 222. McDougle CJ, Holmes JP, Bronson MR, Anderson GM, Volkmar FR, Price LH, Cohen DJ. Risperidone treatment of children and adolescents with pervasive developmental disorders: a prospective open label study. J Am Acad Child Adolesc Psychiatry. 1997 May;36(5):685 93. Stahl SM. Dopamine system stabilizers, aripiprazole, and the next generation of antipsychotics, J Clin Psychiatry. 2001;62(l1).
Derived from this study: PubMed 37811711Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
Official site of the Division of Child and Adolescent PsychiatryLink provided by the sponsor.
Individual participant dataSharing planned: No. No plan at this time.

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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.

Sherie L. Novotny, MD principal investigator

Child and Adolescent Psychiatry, UMDNJ

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

Questions about this trial

What is this clinical trial studying?

A study testing Aripiprazole in people with Autism, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

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 4 inclusion and 10 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 14 Jan 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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 14 Jan 2022). 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?

Clinical Global Impression Improvement (CGI-AD) (time frame: Administered weekly, initial and week 8 reported). 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 NCT00468130, which also lists 2 linked publications.

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 14 Jan 2022.