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NCT03279952 · ClinicalTrials.gov registry record · Phase 4
Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention
A Phase 4 study, sponsored by Milton S. Hershey Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT03279952 is a Phase 4 study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 11 participants.
The verdict
NCT03279952, a Phase 4 study, was terminated before completion, sponsored by Milton S. Hershey Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
There has been an increasing focus on the adverse impacts of irritability, defined as increased tendency towards anger. Irritability worsens peer relationships, family functioning, academic performance and is a risk factor for depression, suicide and substance use and is one of the main reasons why children get referred for treatment. It has been identified as transdiagnostic entity meriting investigation as a treatment target for personalized intervention given its prevalence and morbidity. Most children with prominent irritability also meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) but only a subset of children with ADHD manifest impairing levels of irritability. Irritability levels are only minimally correlated with severity of ADHD symptoms suggesting that irritability is not simply a manifestation of severe ADHD. The first line treatment for irritability in children with ADHD is to optimize the dose of the CNS stimulant. However, there is great heterogeneity in response, with baseline mood lability being the best marker for both improving and worsening irritability. In addition, increased irritability is one of the most common reasons why parents stop these medications. The unpredictability in response to CNS stimulants has led to the increasing use of antipsychotics and other non-evidence based treatments for ADHD. It is unknown what drives this heterogeneity in response in part because little is known about the underlying causal mechanisms for irritability in youth with ADHD. Two areas theorized to contribute to irritability include impairments in learning from experience (instrumental learning) and sensitivity to reward and loss.1 There are objective methods for measuring these domains in children through the use of even-related potentials (ERPs)- synchronous neural activity in response to a stimulus. Reward positivity (RewP) is an ERP component occurring in response to feedback on task performance that can be broken down to separate rewar
Interventions
- DRUG CNS Stimulant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03279952
The ClinicalTrials.gov registry entry for NCT03279952 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CNS Stimulant is the first listed.
NCT03279952 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03279952 about?
NCT03279952 is a clinical study titled "Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention". There has been an increasing focus on the adverse impacts of irritability, defined as increased tendency towards anger. Irritability worsens peer relationships, family functioning, academic performance and is a risk factor for depression, suicide and substance use and is one of the main reasons why ...
What is the current status of trial NCT03279952?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2018-06-01. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT03279952?
The interventions under investigation include: CNS Stimulant (DRUG).
Who is sponsoring clinical trial NCT03279952?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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