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Psychostimulant

Low vs. Normal Dose Psychostimulants for ADHD

Phase 1 & 2
Waitlist Available
Led By Adele Diamond, Ph.D.
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the chronological ages of 6 and 18 years
Currently treated with and responding to oral Psychostimulants >= 20 mg/day and not on a "drug holiday"
Must not have
Have a past history of any severe adverse reaction to lowering of Psychostimulant dose
Taking any psychotropic medication other than on-label Psychostimulants specifically prescribed to treat ADHD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the cognitive performance of children with ADHD who are taking a lower dose of psychostimulants to those taking a moderate to high dose of psychostimulants.

Who is the study for?
Children aged 6-18 with ADHD, either combined or inattentive type, who are stable on a psychostimulant dose of at least 20 mg/day. They must have an IQ above 90 and be able to perform simple tasks and communicate in English. Excluded are those with severe reactions to lower doses of medication, certain mental health conditions, below-average IQ, major sensory impairments, or other medications affecting cognitive skills.
What is being tested?
The study tests if children with ADHD perform better cognitively on a low-dose (half their current dose) versus their normal dose of psychostimulants. It's a double-blind crossover trial where neither the participants nor the researchers know which dosage is being administered first.
What are the potential side effects?
While not explicitly stated here, common side effects of psychostimulants can include decreased appetite, sleep problems, increased heart rate and blood pressure, stomach pain and headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 18 years old.
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I am currently taking and responding well to a daily dose of 20 mg or more of oral Psychostimulants without any breaks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had severe reactions to reducing stimulant medication.
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I am only taking medication for ADHD as prescribed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Executive Functions (difference in performance on the two Psychostimulant doses)
Executive Functions (difference in performance on the two Psychostimulants doses)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Normal-dose Psychostimulant, Low-doseExperimental Treatment1 Intervention
Normal-dose: Dose participants are currently taking as part of their prescription (on more than or equals to 20 mg/day of Psychostimulants) Low-dose: Half the normal dose
Group II: Low-dose Psychostimulants, Normal-doseActive Control1 Intervention
Normal-dose: Dose participants are currently taking as part of their prescription (on more than or equals to 20 mg/day of Psychostimulants) Low-dose: Half the normal dose
Group III: No intervention, No interventionActive Control1 Intervention
This arm is completely no intervention, and is ONLY for healthy volunteers. We are testing healthy volunteers of the same age to give us an estimate of order effects to help us correct for better performance in the 2nd session due simply to taking the same tests twice (note: the tests are Version A and B).

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,404 Total Patients Enrolled
9 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,572 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Adele Diamond, Ph.D.Principal InvestigatorDepartment of Psychiatry, University of British Columbia

Media Library

Psychostimulants (Psychostimulant) Clinical Trial Eligibility Overview. Trial Name: NCT02167048 — Phase 1 & 2
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Normal-dose Psychostimulant, Low-dose, Low-dose Psychostimulants, Normal-dose, No intervention, No intervention
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Psychostimulants Highlights & Side Effects. Trial Name: NCT02167048 — Phase 1 & 2
Psychostimulants (Psychostimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02167048 — Phase 1 & 2
~0 spots leftby Dec 2024