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ACTIVE NOT RECRUITING

NCT02167048

PHASE1/PHASE2

Low-dose vs. Normal-dose Psychostimulants on Executive Functions in Individuals With ADHD

Sponsor: University of British Columbia

View on ClinicalTrials.gov

Summary

This double-blind crossover study aims to compare cognitive performance (e.g., working memory, selective attention and cognitive flexibility) of children ages 6-18 years diagnosed with ADHD of the combined type (ADHD-C) or inattentive-type (ADHD-IA) and currently on \> 20 mg/day of psychostimulants (psychostimulants) on: a) their current dose of psychostimulants, vs. b) a lower-dose of psychostimulants (half of their current dose). The investigators hypothesize that the lower-dose psychostimulants will result in better cognitive performance than moderate-to-high doses of psychostimulants.

Official title: Effects of Low-dose Versus Normal-dose Psychostimulants on Executive Functions in Individuals With Attention-Deficit Hyperactivity Disorder

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2014-06

Completion Date

2024-12

Last Updated

2024-05-08

Healthy Volunteers

Yes

Conditions

Attention Deficit Hyperactivity Disorders

Interventions

DRUG

Psychostimulants

Participants will be tested twice 2 weeks apart. All will continue on their normal Psychostimulant dose up until 3 days before the testing day. 3 days before their 1st testing session, half the participants will start on either their current-dose of Psychostimulant or half their current dose depending on the arm they were randomized to (we provide those pills). To control for different pharmacokinetics of the Psychostimulant medications, a given participant will be tested at roughly the peak time for his/her specific version of Psychostimulant and at the same time of day for his/her two testing sessions.

Inclusion Criteria: * Between the chronological ages of 6 and 18 years * Average to above-average IQ (Parental report of an IQ above 90; we will take their word for it) * Meet DSM-V criteria for ADHD (Combined type or Inattentive type) * Currently treated with and responding to oral Psychostimulants \>= 20 mg/day and not on a "drug holiday" * Stable on current Psychostimulant dose for at least 2 weeks * Able to communicate (understand, speak, and write) in English without the aid of an interpreter * Able to execute simple manual response (button-press) as required for our tasks * The child and parent give assent and consent respectively for the child's participation in this study Exclusion Criteria: * Patients with significant prior or current medical conditions that could impact neuropsychological performance such as traumatic brain injury, hypoxia, or unstable diabetes. * Have any medical condition that could markedly increase sympathetic nervous system activity (e.g. catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (e.g. pseudoephedrine, oral steroids) that has sympathomimetic activity. Note: regular on-label use of inhalers for asthma (e.g., albuterol, steroidal) is permitted * Taking any psychotropic medication other than on-label Psychostimulants specifically prescribed to treat ADHD * Have a major, uncorrected sensory impairment (e.g. significant hearing impairment despite hearing aids) * Lack sufficient English language skills to perform our tasks * Are taking medications other than their specifically prescribed Psychostimulants that may affect cognitive skills * Have a documented history of Dyslexia (this may skew results on our cognitive measures), Bipolar I or II, psychosis, Depression, Autism Spectrum Disorders, or Disruptive Mood Dysregulation Disorder * Have a past history of any severe adverse reaction to lowering of Psychostiumlant dose * Patient has been non-compliant with Psychostimulants or is on a "drug holiday" * Parental report of an IQ below 90 (we will take their word for it)

Locations (1)

Developmental Cognitive Neuroscience Lab, Department of Psychiatry, University of British Columbia

Vancouver, British Columbia, Canada