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

Boston Children's Hospital

Status and phase

Completed

Phase 4

Conditions

Epilepsy

Attention Deficit Disorder With Hyperactivity

Treatments

Drug: Extended Release Methylphenidate (OROS-Methylphenidate)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00323947

K23MH066835 (U.S. NIH Grant/Contract)

DDTR BK-TKND

Details and patient eligibility

About

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.

Full description

Epilepsy is a brain disorder in which clusters of nerve cells in the brain periodically send abnormal signals. The normal pattern of nerve cell activity, therefore, becomes disrupted, which can result in seizures. Some symptoms of epileptic seizures include the following: strange sensations, emotions, or behavior; convulsions; muscle spasms; and loss of consciousness. Children with epilepsy are at risk for other specific disorders, such as ADHD, one of the most common mental disorders in children. ADHD is characterized by impulsiveness, hyperactivity, and inattention. Approximately one third of children with epilepsy also have ADHD. Stimulant medication is a common treatment method for ADHD. The effect of stimulant treatment on epilepsy and seizure frequency, however, is unknown. This study will evaluate the safety and effectiveness of XR-MPH, a stimulant medication, in treating ADHD in children with both ADHD and epilepsy.

People interested in participating in this double-blind study will first attend two visits for interviews and evaluations to determine eligibility for participation. Upon study entry, participants will be randomly assigned to initially receive either XR-MPH or placebo. Medication dosages and duration in the study will depend on participants' weights. Participants will first take either immediate release MPH or placebo "A" for 1 day. Any participants who experience an adverse event will be removed from the study. On Day 2 of treatment, participants assigned to receive XR-MPH will begin taking it, and participants assigned to receive placebo will switch to placebo "B." This treatment phase will continue for 6 days to 4 weeks, depending on weight, and will then be followed by a 1-week medication washout period. Following the washout, participants will switch to the other treatment group for the remainder of the study and will receive either XR-MPH or placebo in the same manner. Participants will attend weekly study visits, at which they will receive medication and undergo assessments of ADHD symptoms and medication side effects. Blood will be drawn to assess medication levels at the first study visit and following both rounds of treatment. Participants who have trouble with transportation to and from the study site may complete some study visits via telephone. Upon study completion, all participants will be offered clinical treatment with the study physician. Follow-up visits will be held every 2 to 6 months for patients who choose to continue receiving care from the study physician.

Enrollment

33 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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.