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

NCT02874690 | Completed Early Phase 1

• 1 other identifier: 2015-4401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Eye-Tracking: Microsaccades and pupil size using Tobii eye tracker

  Eye tracking offers a window into a "hardwired" circuit into the brain in a patient population that may not easily tolerate more invasive diagnostic procedures.

  Pre-dose; Approximately 90 minutes post-dose of methylphenidate

Secondary Outcomes (2)

• Change in Short Interval IntraCortical Inhibition (SICI) using Transcranial Magnetic Stimulation (TMS)

  Pre-dose; Approximately 90 minutes post-dose of methylphenidate

• Change in Resting State Electroencephalogram (EEG)

  Pre-dose; Approximately 90 minutes post-dose of methylphenidate

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo pill received

Drug: Placebo

Methylphenidate

EXPERIMENTAL

Drug: Methylphenidate

Interventions

Methylphenidate DRUG

single dose methylphenidate; 0.3mg/kg, up to 20mg, rounded to the nearest 2.5mg

Methylphenidate

Placebo DRUG

Placebo pill identical in appearance to methylphenidate

Placebo

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ernest Pedapati, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: August 22, 2016
• Study Start: February 19, 2016
• Primary Completion: August 3, 2017
• Study Completion: August 3, 2017
• Last Updated: January 15, 2021

Record last verified: 2020-03

Locations

US (1)