Eye Tracking as a Predictor of Methylphenidate Response in Autism With ADHD

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder

In brief

The overall goal of this research is to use neurophysiological measures to profile strengths and deficits for Attention Deficit Hyperactivity Disorder co-morbidity in Autism Spectrum Disorder to clarify diagnosis and to predict treatment response.

Key facts

Study ID

NCT02874690

Run by

Children's Hospital Medical Center, Cincinnati

People needed

40

Starts

2016-02-19

Expected to finish

2017-08-03

Last updated by the study team

2021-01-15

Who can join

Age: 8 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnostic and Statistical Manual 5 (DSM-V) diagnosis of Autism Spectrum Disorder (ASD) not otherwise specified (NOS) based on a semi-structured review of Diagnostic and Statistical Manual 5 (DSM-V) criteria and mental status examination as well as a a complete systematic patient interview utilizing the Autism Diagnostic Observation Schedule (ADOS)
• Males and females ages 8-21 years.
• Subjects must not be taking any psychotropic drugs affecting glutamate neurotransmission (riluzole, memantine, acamprosate, topiramate, amantadine, among others) which may interfere with TMS recording. If patient is on a home psychostimulants medication this will be held on the day of testing. Subjects may not be taking more than two psychotropic drugs. Dosing of all concomitant psychotropic drugs targeting core social and/or communication impairment must be stable for four weeks prior to randomization. Dosing of all concomitant psychotropic drugs targeting other features associated with ASD (insomnia, inattention, hyperactivity, anxiety, irritability among others) must be stable for two weeks (with the exception of four weeks for fluoxetine) prior to randomization.
• Stable seizure disorder (no seizures in 6 months prior to enrollment; on same anticonvulsant dose > 60 days or )
• Able to participate in neurophysiological testing including Electroencephalogram (EEG) and Transcranial Magnetic Stimulation (TMS) portions of the experiment based on patient comfort and examiner judgement
• Legal guardian has provided written informed consent and the subject has provided written informed assent. Expectation that a majority of subjects will be able to assent but the potential for the younger children and/or those that are cognitively impaired will not be able to assent.

You may not qualify if…

• Subjects exhibiting significant disruptive, aggressive, self-injurious, or sexually inappropriate behavior will not be eligible for enrollment
• Presence of current Diagnostic and Statistical Manual 5 (DSM-V) psychiatric disorders that may require alternative pharmacotherapy or different treatment including psychotic disorders, major affective disorders, obsessive-compulsive disorder, panic disorder, or substance related disorders.
• Presence of any medical condition that would make treatment with methylphenidate (MPH) less safe. Subjects with significant cardiac, hepatic, or renal disease will be excluded due to concerns about pharmacokinetic alterations or adverse effects. Because of the unknown effects of methylphenidate (MPH) on the developing human fetus, females of childbearing potential will be given a urine pregnancy test and required to use a suitable form of birth control during the study. A positive pregnancy test result excludes the subject.
• Presence of any other condition that would make the participants unable to comply with the requirements of the study for any reason.
• Prohibited Concomitant Medications: Methylphenidate is primarily excreted by the kidneys and has few known pharmacokinetic drug interactions. The following medications are not allowed due to the potential for a pharmacodynamic interaction: monoamine oxidase inhibitors or atomoxetine.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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