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CNS Stimulant
CNS Stimulants for ADHD
Hershey, PA
Phase 4
Waitlist Available
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Must not have
Medical contraindications to use of CNS stimulants
Current use of antipsychotic, mood stabilizing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once per week rct phase for total of two weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial aims to study how children with ADHD and chronic irritability respond to CNS stimulant medications. The study will use event related potentials (ERPs), which are small brain responses to specific events,
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Who is the study for?
This trial is for children with ADHD who show signs of impulsive aggression and chronic irritability. Participants must have elevated levels of these behaviors and will undergo a process to find the best dose of CNS stimulants over six weeks, followed by a two-week test comparing their optimized dose with a placebo.Check my eligibility
What is being tested?
The study tests if brain responses (ERPs) can predict how well CNS stimulant medications help reduce aggression and irritability in kids with ADHD at home. It involves optimizing medication dosage, then comparing effects on behavior when taking the drug versus a placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects of CNS stimulants include trouble sleeping, decreased appetite, stomachache, headache, jitteriness or nervousness. Some children may also experience increased irritability or aggression.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot take stimulant medications due to health reasons.
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I am currently taking medication for mood or psychosis.
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I have hearing or vision problems that make it hard for me to use a computer.
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I am currently having thoughts about harming myself.
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My child did not improve after trying two different ADHD medications.
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I am currently experiencing a major depressive episode.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly for two weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly for two weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Open label dose opt: ADHD RS 5 clinician interview
RCT phase abridged Revised modified overt aggression scale (RMOAS)
RCT phase: Guardian rated Affective reactivity Index (ARI)
Secondary study objectives
Columbia Suicide Severity Rating Scale (CSSRS)
Open label dose opt Clinical Global Impressions: Impairment and Severity (CGI I/S)
Open label dose opt affective reactivity index clinician interview (CARI)
+23 moreSide effects data
From 2016 Phase 3 trial • 230 Patients • NCT0110984963%
loss of appetite
49%
irritability
48%
anxiety
42%
skin picking
41%
trouble sleeping
35%
depressed mood
32%
stomachache
29%
headache
26%
dull, listless
20%
socially withdrawn
18%
motor/verbal tics
15%
buccal movements
1%
abdominal pain
1%
appendicitis
1%
self injurious behavior
1%
shortness of breath
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Optimzed
Behavior Therapy
ER Stimulant
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: open label dose optimization (phase one)Experimental Treatment1 Intervention
In this first treatment phase, all participants will have their dose of CNS Stimulant optimized over 6 visits under open label conditions. This arm will use any FDA approved CNS stimulant for pediatric ADHD at their approved dose. By the end of this phase, the optimal dose for the next phase will be identified.
Group II: Blinded optimal dose (phase two)Active Control1 Intervention
In this second treatment phase of the study, all participants will receive under blinded conditions their optimal dose of CNS stimulant from the prior phase for a total of 7 days
Group III: Placebo (phase two)Placebo Group1 Intervention
In this second treatment phase of the study, all participants will receive placebo under blinded conditions for a total of 7 days
Find a Location
Closest Location:Penn State Health Dept of Psychiatry· Hershey, PA
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
514 Previous Clinical Trials
2,872,464 Total Patients Enrolled