Methylphenidate for Attention Problems After Pediatric TBI

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-08-31

Brief Summary

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Traumatic Brain Injury (TBI) - methylphenidate treatment

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Healthy Volunteers

COMPLETED PHASE1

Detailed Description

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The objectives of the study are to (1) determine the efficacy and dose-response of methylphenidate treatment of attention problems after pediatric traumatic brain injury (TBI) and (2) provide a better understanding of the relationship of a prior history of attention deficit hyperactivity disorder (ADHD), ADHD subtypes after TBI, executive function, and attentional control to treatment efficacy. The proposed clinical trial will enroll 50 children, age 6-17 years, with attention problems \>6 months after moderate to severe TBI into a randomized, double-blind, placebo-controlled, cross-over design trial with 3 dose conditions (low, medium, and high).

Conditions

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Traumatic Brain Injury TBI ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methylphenidate

The study medication will consist of identical capsules filled Concerta® over-encapsulated to preserve double-blinding. The weekly dosages will be low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial. Weekly ratings monitoring behavioral and side effect symptoms score and the Pittsburgh Side Effects Rating Scale.

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

Placebo

The study medication will consist of identical capsules filled with an inert white power (placebo). Weekly ratings monitoring behavioral and side effect symptoms score and the Pittsburgh Side Effects Rating Scale.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Methylphenidate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Concerta

Eligibility Criteria

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Inclusion Criteria

* Between ages of 6-17
* Sustained Moderate to Severe TBI
* TBI occurred at least 6 months prior to beginning the study
* TBI occurred no earlier than 5 years of age
* Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale

Exclusion Criteria

* History of developmental disability or mental retardation
* Current active participation in ADHD-related behavioral intervention
* History of psychiatric condition requiring an inpatient admission in past 12 months
* Actively taking medications with a contraindication to Concerta that cannot be discontinued
* Current use of stimulant medication or ADHD specific medications that cannot be discontinued
* Non-blunt head injury
* Family history of arrhythmia
* Pregnancy

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No