Could a common ADHD drug ease hyperactivity in kids with autism?
NCT ID NCT00498173
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug atomoxetine in 60 children with autism who also had significant hyperactivity, inattention, or impulsivity. Over 8 weeks, researchers measured changes in ADHD symptoms using a standard rating scale. The goal was to see if atomoxetine could safely reduce these symptoms in children with autism.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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60 people
The number who actually took part.
- Start date
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Jul 2007
- Finished
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Oct 2015
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 15 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of an autism spectrum disorder (autistic disorder, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified). * Significant hyperactivity, inattention, or impulsivity as determined by a score on an investigator-administered ADHD Rating Scale (ADHDRS)-Home Version that is at least 1.5 standard deviations above the mean for age and sex * Parent/caregiver's primary complaint about the child is inattention, hyperactivity, and/or impulsivity ("ADHD" symptoms) * Symptoms present for 6 months prior to study entry * Psychotropic drug-free for at least 2 weeks prior to starting study medication. This drug-free period will be 5 weeks for fluoxetine (Prozac). Exclusion Criteria: * Weighs less than 15 kg (about 33 pounds) * Any another psychiatric disorder that may require a different treatment, including psychotic disorders, major affective disorders, obsessive-compulsive disorder, panic disorder, or substance-related disorders * Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of Rett's disorder or childhood disintegrative disorder * Presence of extreme aggression or self-injury * Currently taking an effective psychotropic drug * Currently using other medications that may be unsafe to take with atomoxetine (e.g., potent CYP 2D6 inhibitors, intravenous albuterol, monoamine oxidase inhibitors\[MAO\]) * Inability to swallow study medication * Presence of a medical condition that would make treatment with atomoxetine unsafe (e.g., unstable hypertension or cardiac disease, asthma requiring frequent treatment with albuterol, narrow angle glaucoma, pregnancy, etc.) * Mental age of less than 18 months * Previous adequate trial of atomoxetine * Previous evidence of hypersensitivity or an allergic reaction to atomoxetine * Clinically significant abnormalities in laboratory measures indicating an undiagnosed medical condition as determined by the study physician in discussion with the participant's primary care physician * Clinically significant abnormalities on ECG as determined by a pediatric cardiologist * Pregnant * Initiation of a new psychosocial intervention within 90 days prior to starting study medication. Participants who have recently had a significant change in their psychosocial interventions will not be eligible until this intervention has been stable for 90 days in order to avoid confounding results of the study. Stable interventions (e.g., speech and occupational therapy) will be allowed to continue during the course of the study. Minor changes in ongoing treatment (e.g., missed therapy sessions due to holiday/vacation planned break in therapy due to school holidays) will not be considered significant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Christian Sarkine Autism Treatment Center at Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
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Lurie Center - MassGeneral Hospital
Lexington, Massachusetts, 02421, United States
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Other studies related to the condition(s) this trial covers.
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