Methylphenidate for Treating Attention Deficit Hyperactivity Disorder in Children With Both ADHD and Epilepsy

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and effectiveness of extended release methylphenidate (XR-MPH) in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and epilepsy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Speaks English

• Intelligence Quotient (IQ) of greater than 35 and scores greater than 35 on the Scales of Independent Behavior - Revised (SIB-R) Broad Independence Scale (both IQ and adaptive functioning at the Moderate Mental Retardation level or higher)

• Diagnosis of epilepsy by International League Against Epilepsy (ILEA) criteria 26 (repeated, afebrile, unprovoked seizures with a seizure within the past 5 years)

• Diagnostic and Statistical Manual (DSM)-IV diagnosis of ADHD

• Scores at least 4 on the CGI severity scale for ADHD

• Scores greater than 90% on the ADHD Rating Scale (ADHD RS), Parent Version; investigator scored for age and sex on either the inattentive, hyperactive-impulsive, or total score at first visit

• Has not taken stimulants or alpha-adrenergic medications for more than 2 weeks prior to study entry

• If taking antidepressants, neuroleptics, or lithium, doses have been stable for more than 4 weeks

• Currently on an antiepileptic drug (AED) regimen with stable doses for more than 4 weeks prior to study entry

• Seizure-free for more than 1 month prior to study entry

• Prescribing clinician for epilepsy anticipates the need for a stable AED regimen for the duration of the study

• Guardian gives permission for study personnel to communicate with prescribing epilepsy clinician

• Teacher agrees to fill out ADHD RS at baseline and at the end of each arm of the study

Exclusion Criteria:

• Has had a seizure within the month preceding study entry

• Change in AED regimen or dose within 4 weeks of study entry

• History of moderate or severe adverse event related to MPH

• History of any psychotic disorder

• Current acute major depression or bipolar mania

• Current psychiatric disorder requiring pharmacotherapy (other than ADHD)

• Unstable significant medical condition other than epilepsy

• Any known conditions that may make treatment with MPH medically inadvisable

• Not currently working with a physician for epilepsy treatment

• Previously participated in a trial that provided adequate treatment with XR-MPH

• Weighs less than 9 kg

• Pregnant

• Unwilling to use an effective form of contraception

• Child has taken a stimulant (MPH, an amphetamine preparation, or pemoline), alpha-adrenergic (clonidine or guanfacine), or other ADHD medication within 2 weeks of the screening telephone interview. Children will not be withdrawn from psychotropic medications in order to be enrolled in the study.