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CNS Stimulants for ADHD
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.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 3 trial • 230 Patients • NCT01109849Trial Design
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Who is running the clinical trial?
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- I am aged 5-12, diagnosed with ADHD, have moderate irritability, and speak English.
- Group 1: medication arm
- 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.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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