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.

Must not have

Prescribed or taking a stimulant dosage outside of recommended therapeutic range.

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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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I am between 4 and 13 years old.

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I have been diagnosed with ADHD.

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I am already taking prescribed stimulant medication for AD/HD at the correct dose for my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking a stimulant medication at a dose not recommended by my doctor.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.