Your session is about to expire
← Back to Search
Stimulant
Stimulants for ADHD
Phase 4
Recruiting
Led By Matthew J O'Brien, PhD
Research Sponsored by Matthew J O'Brien, PhD, BCBA-D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be a child or adolescent between the ages of 4 years, 0 months, and 13 years, 0 months (participants must not be older than 12 years, 11 months).
Participant must have a valid diagnosis of attention deficit/hyperactivity disorder (AD/HD). No specification of type will be necessary.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8; we will compare data from weeks 1, 3, 5, and 7 (on medication) versus weeks 2, 4, 6, and 8 (off medication)
Awards & highlights
Study Summary
This trial will help researchers to understand how well stimulant medication works for children and adolescents with AD/HD who exhibit disruptive behavior, as well as how much they may prefer or choose to participate in activities under medication and non-medication conditions.
Who is the study for?
Children and adolescents aged 4 to under 14 with disruptive behavior and diagnosed ADHD, already on a prescribed stimulant medication. Excluded are those with autism, conduct disorder, or moderate to profound intellectual disability, or on non-therapeutic stimulant dosages.Check my eligibility
What is being tested?
The trial tests how stimulant medication affects disruptive behaviors in kids with ADHD through preference assessments (choice of activities), functional analyses (behavior triggers), and choice assessments (impulse control). Participants alternate between medicated and non-medicated states across eight visits.See study design
What are the potential side effects?
While not explicitly listed for this study, common side effects of stimulants may include decreased appetite, stomach pain, sleep problems, increased heart rate/blood pressure; individual experiences can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 4 and 13 years old.
Select...
I have been diagnosed with ADHD.
Select...
I am already taking prescribed stimulant medication for AD/HD at the correct dose for my age.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8; we will compare data from weeks 1, 3, 5, and 7 (on medication) versus weeks 2, 4, 6, and 8 (off medication)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8; we will compare data from weeks 1, 3, 5, and 7 (on medication) versus weeks 2, 4, 6, and 8 (off medication)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Behavioral Function
Change in Item Preference
Change in Preference for Social and Non-Social Activities
+1 moreSecondary outcome measures
Compliance
Item Engagement
Rate of Problem Behavior
Side effects data
From 2014 Phase 4 trial • 41 Patients • NCT0205869325%
Headache
13%
Dry mouth
13%
Agitation
6%
Decreased appetite
6%
Body ache
6%
Insomnia
6%
Nausea
6%
Mild heart tremor
6%
Racy feelings
6%
Acid reflux
6%
Sinusitis
6%
Injury: slip and fall, bruising
6%
Tachycardia
6%
Weight loss
6%
Word finding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 2(B): MSA/MSA
Group 1(A): Placebo/MSA
Trial Design
1Treatment groups
Experimental Treatment
Group I: Subjects on stimulant medicationExperimental Treatment1 Intervention
All participants: Children and adolescents diagnosed with AD/HD, displaying disruptive behavior, and taking stimulant medication.
Find a Location
Who is running the clinical trial?
Matthew J O'Brien, PhD, BCBA-DLead Sponsor
1 Previous Clinical Trials
152 Total Patients Enrolled
Matthew J O'Brien, PhD5.01 ReviewsPrincipal Investigator - University of Iowa
University of Iowa
1 Previous Clinical Trials
152 Total Patients Enrolled
5Patient Review
Dr. O'Brien is extremely knowledgeable, gentle, kind, and patient.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have episodes of crying or screaming loudly, sometimes accompanied by body movements.I am taking a stimulant medication at a dose not recommended by my doctor.I am between 4 and 13 years old.I have been diagnosed with ADHD.I am already taking prescribed stimulant medication for AD/HD at the correct dose for my age.You have a history of hurting yourself by hitting, biting, banging your head, pinching, or scratching yourself to the point of causing visible skin damage.You have a history of physically or verbally harming others, such as hitting, kicking, biting, or insulting them.I have been diagnosed with ADHD.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects on stimulant medication
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT03420339 — Phase 4
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger