ADHD - Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD, epilepsy
Brief summary
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
Interventions
DRUGmethylphenidate hydrochloride (Jornay PM)
all participants will receive active treatment
Sponsors
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open label, flexible dose
Intervention model description
observational
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria: * Established diagnosis of epilepsy that requires treatment with anti-seizure medication. * No episodes of seizure clusters or status epilepticus within 30 days prior to entry into the study. * Diagnosis of ADHD with functional impairment. * Good general health as determined by medical history and physical examination, including stable vital signs. * Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subject's disease process and compliance with treatment.
Exclusion criteria
* • Previous allergic or hypersensitivity reactions to stimulant medicines including Jornay PM® * Active substance abuse or dependence within 30 days of enrollment * Epilepsy that is unstable or with seizure frequency that exceeds four events per month, based on an average over the previous three months * DSM-V diagnosis of psychotic illness or imminent risk of harm to self or others. * Current use of stimulants to treat ADHD * Serious or unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes. * Unstable cardiac illness such as arrythmias or cardiomyopathy. * Participation in a previous experimental drug study within 30 days of baseline visit. * Estimated IQ\<70 as indicated by clinical assessment to the degree that rating scales may be invalid * Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression-Improvement | 12 weeks | Clinical Global Impression-Improvement (CGI-I) is a 1-7 point scale to assess improvement. 1 reflects "very much improved" and 7 reflects "very much not improved" |
Countries
United States
Contacts
CONTACTNeuropsychiatry Study Coordinator
PRINCIPAL_INVESTIGATORJay Salpekar, MD
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Outcome results
None listed