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CNS Stimulant

CNS Stimulants for ADHD

Phase 4
Recruiting
Led By Raman Baweja, MD, MS
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 weeks
Awards & highlights

Study Summary

This trial is investigating whether children with ADHD and prominent irritability have abnormalities in their brain activity in response to feedback on task performance, which may be a marker for severity of irritability and subsequent response to CNS stimulants.

Who is the study for?
This trial is for children aged 5-12 with ADHD who speak English and have moderate irritability. They must not have serious neurological issues, autism traits, severe developmental delays, or be on certain psychotropics. Kids with visual/hearing impairments or latex allergies are excluded.Check my eligibility
What is being tested?
The study tests how CNS stimulant medications affect irritability in kids with ADHD by looking at brain responses to rewards and errors. It aims to find markers predicting treatment response and understand the underlying causes of irritability.See study design
What are the potential side effects?
CNS stimulants may increase irritability in some children; this is a common reason why parents discontinue these meds. Other side effects can include difficulty sleeping, decreased appetite, stomachaches, headaches, jitteriness, and mood swings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ADHD symptoms
ODD symptoms
change in parent rated irritability on the DBD irritability score
Secondary outcome measures
Erythrocyte Indices
Error related negativity (ERN) amplitude
Event related potentials (ERP)
+4 more

Side effects data

From 2016 Phase 3 trial • 230 Patients • NCT01109849
59%
anxiety
49%
skin picking
39%
loss of appetite
34%
irritability
29%
headache
27%
stomachache
27%
trouble sleeping
24%
buccal movements
24%
dull, listless
22%
socially withdrawn
22%
depressed mood
20%
motor/verbal tics
2%
self injurious behavior
2%
aggression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Behavior Therapy
ER Stimulant
Dose Optimzed

Trial Design

1Treatment groups
Experimental Treatment
Group I: medication armExperimental Treatment1 Intervention
CNS Stimulant

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
491 Previous Clinical Trials
2,798,758 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
68 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Raman Baweja, MD, MSPrincipal Investigator - Penn State Health
Penn State Geisinger Rehabilitation Center, Penn State Milton S. Hershey Medical Center, Pennsylvania Psychiatric Institute

Media Library

CNS Stimulant (CNS Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT03279952 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: medication arm
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: CNS Stimulant Highlights & Side Effects. Trial Name: NCT03279952 — Phase 4
CNS Stimulant (CNS Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03279952 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants accepted into this medical experiment?

"Aye, clinicaltrials.gov has evidence that this inquiry is currently recruiting participants. This project was first uploaded on January 1st 2018 and was recently modified on July 18th 2022. The research team aims to enlist 47 individuals at a single medical facility."

Answered by AI

Does this research protocol involve individuals aged sixty-five or above?

"The criteria for taking part in this trial entails being aged between 5 and 12 years old. Furthermore, there are 96 trials available to minors and 28 aimed at those over the age of 65."

Answered by AI

Am I eligible to register for this research trial?

"This clinical trial is enrolling 47 patients between the ages of 5 and 12 that have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Crucially, all potential participants must meet one or more of the following criteria: CNS stimulant medications are commonly prescribed within this age range; Mixed amphetamine salt has already been approved for children aged 3 years or older; methylphenidate has also seen usage in FDA-funded studies on pre-school kids; American Pediatric Association guidelines recommend its use."

Answered by AI

Is this treatment considered hazardous to human health?

"The safety of this particular medication is rated at a 3, being that it has reached Phase 4 in its trial period and thus been approved."

Answered by AI

What are the essential aims of this research endeavor?

"The primary measure for gauging the efficacy of this trial is a reduction in ADHD symptoms at Baseline and 6 weeks. Secondary outcomes include Parent's scores from the Affective Reactivity Index to assess irritability, Impairment Rating Scale (IRS) to evaluate functioning across multiple domains, and Modified Overt Aggression Scale (MOAS) to track aggressive behaviour."

Answered by AI

Is the recruitment process for this trial still ongoing?

"Per the data hosted on clinicaltrials.gov, this experiment is actively looking for volunteers and has been since 1/1/2018; it was last modified on 7/18/2022."

Answered by AI
~2 spots leftby Jul 2024