CompletedNot Applicable

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

United States13 participantsStarted 2006-05

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

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Global Impression Improvement (CGI-AD)

Timeframe: Administered weekly, initial and week 8 reported

Trial details

NCT IDNCT00468130

SponsorUniversity of Medicine and Dentistry of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2021-11-11

View on ClinicalTrials.gov More Autism trials