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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 belowSelect...
I am between 6 and 18 years old.
Select...
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:Select...
I've had severe reactions to reducing stimulant medication.
Select...
I am only taking medication for ADHD as prescribed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
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).
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had severe reactions to reducing stimulant medication.You have not been taking your prescribed psychostimulant medication or have taken a break from it.I don't have a condition or take daily medication that increases my nervous system activity, except for asthma inhalers.I can press a button when needed.You have a documented history of dyslexia, bipolar disorder, psychosis, depression, autism, or disruptive mood dysregulation disorder.I have a medical condition like a severe head injury or uncontrolled diabetes that could affect my brain function.I am between 6 and 18 years old.I have been on the same dose of my ADHD medication for at least 2 weeks.I am not on any medication that affects my thinking, other than my prescribed psychostimulants.I am currently taking and responding well to a daily dose of 20 mg or more of oral Psychostimulants without any breaks.You have been diagnosed with ADHD according to the DSM-V criteria.I am only taking medication for ADHD as prescribed.
Research Study Groups:
This trial has the following groups:- Group 1: Normal-dose Psychostimulant, Low-dose
- Group 2: Low-dose Psychostimulants, Normal-dose
- Group 3: No intervention, No intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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