CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 168 enrolled
Drug / intervention
Methylphenidate HCl +3 moredrug
Likely dose
Methylphenidate HCl 18 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00796302
NCT00796302Phase 4Completed
CompareCT.gov

Stimulant and Risperidone in Children With Severe Physical Aggression

Michael Aman·interventional·Posted Nov 24, 2008·Updated Jul 26, 2017

In Brief

A Phase 4 clinical trial evaluating Methylphenidate HCl, Risperidone, and 2 other interventions for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 168 participants across 4 sites.

Detailed Summary

This study will determine the safety and effectiveness of two medications for treating aggression in children with attention deficit hyperactivity disorder (ADHD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Disorder With Hyperactivity
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 24, 2008
Enrollment StartAug 1, 2008
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.6 years ago

Interventions

Methylphenidate HCldrug

For children weighing less than 25 kg, the dose will be titrated at 18 mg for the first 7 days, 36 mg for the next 4 days, and, if needed, 54 mg for the next 4 days. For children weighing more than 25 kg, the dose will be titrated at 18 mg for the first 4 days, 36 mg for the next 3 days, 54 mg for the next 4 days, and 72 mg for the next 3 days. Once the child's optimal dose is established, he or she will continue on that dose for the rest of the 21-week trial. One pill is taken once daily.

Risperidonedrug

For children weighing less than 45 kg, the dose will start at 0.5 mg at night. After 4 days, the child's dose may be increased to 1 mg a day. On Day 8, the child's dose may be increased to 1.5 mg a day. On Day 16, the child's dose may be increased to 2.0 mg a day. On Day 22, the child's dose may be increased to 2.5 mg a day. For children weighing more than 45 kg, the dose will start at 0.5 mg at night. After 4 days, the child's dose may be increased to 1.0 mg a day. On Day 8, the child's dose may be increased to 1.5 mg a day. On Day 12, the child's dose may be increased to 2.0 mg a day. On Day 15, the child's dose may be increased to 2.5 mg a day. On Day 18, the child's dose may be increased to 3 mg a day. On Day 23, the child's dose may be increased to 3.5 mg a day.

Parent Management Training (PMT)behavioral

PMT will include individual parent sessions held weekly for 9 weeks, with two booster sessions to be completed during the 3-month extension. Sessions will include development of problem-solving skills and behavior management strategies, practice activities, and role-playing with the behavioral therapist.

Placebodrug

One pill will be taken once daily for the first 4 days and then twice daily until Week 21.