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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of British Columbia
• Treatments: Central Nervous System Stimulants

Criteria

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)