Treatment of Severe Childhood Aggression (The TOSCA Study)

Summary

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

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

Methylphenidate HCl

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.

DRUG

Risperidone

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.

BEHAVIORAL

Parent Management Training (PMT)

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.

DRUG

Placebo

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Michael Aman

  lead OTHER

Principal Investigators

• Michael G. Aman, PhD · Ohio State University

• Oscar G. Bukstein, MD, MPH · University of Pittsburgh

• Kenneth D. Gadow, PhD · State University of New York Stony Brook

• Robert L. Findling, MD · Case Western Reserve University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-08-31

Primary Completion

2012-11-30

Completion

2012-11-30

Countries

• United States

Study Locations