Status:
TERMINATED
Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
ADHD
Eligibility:
All Genders
5-12 years
Phase:
PHASE4
Brief 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 performanc...
Detailed Description
There has been an increasing focus on the adverse impacts of irritability, defined as increased tendency towards anger.In children, irritability manifests as a persistently negative mood and frequent ...
Eligibility Criteria
Inclusion
- Ages 5-12: CNS stimulant medications are commonly used and well studies in this age range (Mixed amphetamine salt has been approved for children age 3 + and methylphenidate has been used in FDA funded studies on preschool children; American Pediatric Association guidelines are also recommend for the preschool children) and these are the age ranges where children are most likely to present for treatment of irritability.
- 2\. Meets diagnostic criteria for any presentation type of ADHD. ADHD status will be assessed on the NIMH Computerized Diagnostic Interview Schedule for Children (C-DISC).54 The C-DISC will also be used to assess psychiatric comorbidity, with diagnoses confirmed by an MD/PhD prior to eligibility decisions. Symptom severity for ADHD, irritability and Oppositional Defiant Disorder (ODD) will be assessed using the Disruptive Behavior Disorders (DBD) Parent Rating Scale which is similar to the Vanderbilt, rating symptoms on a 0-3 likert.24 In accordance with previous studies of irritability in ADHD, the DBD irritability score (range 0-9) will be the primary outcome, with a moderate level of irritability (≥5) required for entry.12 DMDD status will be assessed using Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (KSADS-PL) but DMDD will not be required for entry as subthreshold levels of irritability produce significant impairment.7 3. Sex: male or female 4. Fluent in written and spoken English.
Exclusion
- Age \<5 years of age or \>12 years of age.
- Children with significant visual or hearing deficits or sensitivity to loud noises as test performance requires intact hearing and vision.
- Children with a latex allergy as the sensors used in electrophysiology assessments have a latex component.
- Serious neurological conditions that impacts cognition, such as an active seizure disorder
- Current psychotropics other than FDA approved ADHD medications, as medication will be withheld on testing days. Unlike most other psychotropic medications, CNS stimulants can be withheld for brief periods and acutely restarted with no safety risks and lengthy titration process. Numerous ADHD studies have safely withdrawn these medications or substituted inert placebo for testing or clinical observation. Children taking an approved nonstimulant for ADHD plus a CNS Stimulant medication will be allowed to participate and will just have their CNS stimulant dose withheld on testing days.
- Prominent traits of autism spectrum disorder (Social Communication Questionnaire Score \>15), marked developmental delay or psychiatric conditions requiring urgent treatment (mania, psychoses, suicidal ideation).
- Parent or child not fluent in English
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03279952
Start Date
June 1 2018
End Date
June 30 2024
Last Update
August 26 2025
Active Locations (1)
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1
Penn State Hershey
Hershey, Pennsylvania, United States, 17036