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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00796302 |
This study will determine the safety and effectiveness of two medications for treating aggression in children with attention deficit hyperactivity disorder (ADHD).
Condition | Intervention | Phase |
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Attention Deficit Disorder With Hyperactivity |
Drug: Methylphenidate HCl Drug: Risperidone Behavioral: Parent Management Training (PMT) Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Stimulant and Risperidone in Children With Severe Physical Aggression |
Estimated Enrollment: | 160 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
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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. 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.
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.
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2: Active Comparator
Children will receive methylphenidate HCl and placebo instead of the active risperidone. Parents will receive parent management training.
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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.
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.
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ADHD is characterized by inattention, impulsivity, and hyperactivity. Children with ADHD sometimes also have disruptive behavior disorders (DBDs), such as conduct disorder (CD), which is estimated to develop in 20% to 40% of children with ADHD, and oppositional defiant disorder (ODD), which is estimated to develop in 33% to 50% of children with ADHD. These two disorders place youth at risk of other psychiatric disorders, especially substance abuse disorders. Several medications have been tested to treat conduct disorders in aggressive children, and, among these, risperidone and methylphenidate hydrochloride (HCl) have relatively good records of safety and tolerability. Psychostimulants, such as methylphenidate HCl, can reduce the symptoms in some, but not all, children with DBDs. Combining methylphenidate HCl with risperidone may be one way to increase the effectiveness of drug treatments. This study will compare the effectiveness of methylphenidate HCl alone versus methylphenidate HCl combined with risperidone for treating aggressive behavior in children with ADHD. Participation in this study will last 1 year. The child participant and a parent will attend all study visits. Two initial visits will involve a battery of baseline tests, including a psychological clinical interview, physical examination, lab tests, and an electrocardiogram (ECG). The parents will undergo a parent education session and complete questionnaires about their child's behavior, emotions, and medication side effects. The child will have his or her vital signs measured and complete tests of verbal memory and attention and impulsiveness. After the second visit, the child participant will be randomly assigned to receive either methylphenidate HCl alone or methylphenidate HCl plus risperidone.
For the next 3 weeks, all child participants will take methylphenidate HCl at a dose that will start low and gradually be increased until the most effective dose is determined. For the next 6 weeks, child participants will add either risperidone or a placebo to their regimen of methylphenidate HCl. This second medication will also be started at a low dose and raised to appropriate levels of tolerability. During the 9 weeks of medication adjustment, participants will attend weekly study visits to complete questionnaires and have their vital signs measured. Parents will attend education sessions at each of these visits. The child's teacher will also fill out weekly questionnaires on the child's behavior. Every 3 weeks, child participants will be tested on verbal memory, attention, and impulsiveness. After the 9-week period, child participants will again undergo a physical exam, lab tests, and an ECG.
At this point, if the child's behavior has improved, the child will continue the same treatment for the next 3 months. Monthly study visits will include parent education sessions and recording of parent and teacher evaluations of the child. All participants will attend a 1-year follow-up visit that will include previous assessments.
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
State University of New York Stony Brook | Recruiting |
Stony Brook, New York, United States, 11794 | |
Contact: Jayne Schneider, PhD 631-632-3091 jaschnei@notes.cc.sunysb.edu | |
Principal Investigator: Kenneth D. Gadow, PhD | |
United States, Ohio | |
Ohio State University Nisonger Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Krystina Wilson, BA 614-292-7022 Krystina.Wilson@osumc.edu | |
Contact: Sarah Hersch, BABS 614-688-3375 Sarah.Hersch@osumc.edu | |
Principal Investigator: Michael G. Aman, PhD | |
Sub-Investigator: L. Eugene Arnold, MD, MEd | |
Sub-Investigator: Yaser Ramadan, MD | |
Case Western Reserve University | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Nicole Kovach 216-844-3922 Nicole.Kovach@UHhospitals.org | |
Contact: Eric King, MA 216-844-6252 Eric.King@UHhospitals.org | |
Principal Investigator: Robert L. Findling, MD | |
United States, Pennsylvania | |
University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Jennifer Baker 412-246-5651 bakerjl@upmc.edu | |
Contact: Heidi Kipp, MA 412-246-5661 kipphl@upmc.edu | |
Principal Investigator: Oscar G. Bukstein, MD, MPH |
Principal Investigator: | Michael G. Aman, PhD | Ohio State University |
Principal Investigator: | Oscar G. Bukstein, MD, MPH | University of Pittsburgh |
Principal Investigator: | Kenneth D. Gadow, PhD | State University of New York Stony Brook |
Principal Investigator: | Robert L. Findling, MD | Case Western Reserve University |
Responsible Party: | Ohio State University ( Michael Aman, PhD, Professor of Psychology and Psychiatry ) |
Study ID Numbers: | R01 MH077907, DSIR 84-CTS, 1R01MH077907-01A2, 1R01MH077676-01A2, 1R01MH077750-01A2, 1R01MH077997-01A2 |
Study First Received: | November 21, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00796302 |
Health Authority: | United States: Federal Government |
Conduct Disorder Attention Deficit and Disruptive Behavior Disorders |
Conduct Disorder Risperidone Attention Deficit and Disruptive Behavior Disorders Methylphenidate Dyskinesias Serotonin Behavioral Symptoms Signs and Symptoms |
Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Aggression |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Dopamine Antagonists Central Nervous System Stimulants Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |