CompletedPhase 3

Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism

United States81 participantsStarted 2005-09

Plain-language summary

This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.

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: * Weight of at least 15 kg (33.75 lbs) * Meets DSM-IV criteria for autistic disorder * Outpatient * Medication-free for at least 2 weeks prior to baseline for all psychotropic medications. More information about this criterion, including exceptions, can be found in the protocol. * Clinical Global Impression Scale Severity score (CGI-S) of at least 4 * Irritability subscale of the Aberrant Behavior Checklist (ABC) score of at least 18 * An IQ of at least 35 or a mental age of at least 18 months * In good physical health Exclusion Criteria: * Meets DSM-IV criteria for Asperger's disorder, Rett's disorder, childhood disintegrative disorder, any other pervasive developmental disorder (PDD), schizophrenia, psychotic disorder, or bipolar disorder * Current or past history of alcohol or other substance abuse within 6 months of study entry * Comorbid neurodevelopmental disorder with possible association to autism (e.g., fragile-X syndrome, tuberous sclerosis) * A significant medical condition such as heart, liver, kidney, or lung disease, or a seizure disorder * Pregnant * Prior adequate use of aripiprazole. More information about this criterion can be found in the protocol. * Evidence of hypersensitivity to aripiprazole * History of neuroleptic malignant syndrome

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

Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase

Timeframe: Weeks 1, 2, 3, 4, 6, and 8

Odds of Improvement as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2)

Timeframe: Weeks 1, 2, 3, 4, 6 and 8

Trial details

NCT IDNCT00198107

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-09

Results submitted2018-04-30

View on ClinicalTrials.gov More Autistic Disorder trials