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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: | NCT00794625 |
This study will determine the advantages and disadvantages of adding one of two different types of drugs to stimulant treatment for reducing aggressive behavior in children with attention deficit with hyperactivity disorder (ADHD).
Condition | Intervention | Phase |
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Attention Deficit Disorder With Hyperactivity |
Drug: Valproate Drug: Risperidone Drug: Placebo Drug: Stimulant medication Behavioral: Behavioral family counseling |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Adjunctive Treatment With Divalproex or Risperidone for Aggression Refractory to Stimulant Monotherapy Among Children With ADHD |
Estimated Enrollment: | 270 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
During Phase 1, participants will receive a stimulant medication. If they do not respond to the stimulant, they will add valproate and behavioral family counseling to their treatment during Phase 2. If they do not respond to valproate, they will be switched to risperidone.
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Drug: Valproate
Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
Drug: Risperidone
Standard therapeutic doses of risperidone for 8 weeks
Drug: Stimulant medication
Stimulant medication standard in the care of ADHD, such as methylphenicate or dextroamphetamine
Behavioral: Behavioral family counseling
Weekly behavioral counseling with a therapist
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2: Experimental
During Phase 1, participants will receive a stimulant medication. If they do not respond to the stimulant, they will add risperidone and behavioral family counseling to their treatment during Phase 2. If they do not respond to risperidone, they will switch to valproate.
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Drug: Valproate
Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
Drug: Risperidone
Standard therapeutic doses of risperidone for 8 weeks
Drug: Stimulant medication
Stimulant medication standard in the care of ADHD, such as methylphenicate or dextroamphetamine
Behavioral: Behavioral family counseling
Weekly behavioral counseling with a therapist
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3: Placebo Comparator
During Phase 1, participants will receive a stimulant medication. If they do not respond to the stimulant, they will add placebo and behavioral family counseling to their treatment during Phase 2.
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Drug: Placebo
An inactive substance at identical dosing to active treatments for 8 weeks
Drug: Stimulant medication
Stimulant medication standard in the care of ADHD, such as methylphenicate or dextroamphetamine
Behavioral: Behavioral family counseling
Weekly behavioral counseling with a therapist
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Attention deficit with hyperactivity disorder (ADHD) is a common childhood mental disorder that affects 3% to 5% of all American children. Symptoms of ADHD commonly include inability to focus or exercise normal inhibition, and in some cases, aggressive behavior. Approximately 33% to 50% of children with ADHD develop oppositional defiant disorder (ODD), and about 20% to 40% develop a conduct disorder (CD). These disorders are characterized by defiant, belligerent, and otherwise aggressive behavior. Treatment for ADHD generally includes use of stimulant medications that decrease impulsivity and increase attentiveness, such as methylphenidate (Ritalin) or dextroamphetamine (Dexedrine), but these do not always affect aggression. To treat aggression in ADHD, many physicians prescribe additional medications, including the mood stabilizing medication valproate and the antipsychotic medication risperidone.
There is no clinical evidence proving that using multiple types of medications is safe and effective. This study will treat children with ADHD and aggression with a combination of stimulants and antipsychotic or mood stabilizing medications to determine whether the aggressive behaviors and ADHD symptoms are reduced without harmful side effects.
This study has two phases. During the first phase, which will last 3 to 6 weeks, participants will be treated with normal ADHD stimulant medications. During the second phase, those whose aggressive behavior is not effectively suppressed by stimulant medication alone will then be randomly assigned to also receive valproate, risperidone, or placebo for 8 weeks. After 8 weeks, children whose aggression persists will be switched from either valproate to risperidone or risperidone to valproate for another 8 weeks. Those on placebo will not switch medications. All participants will attend weekly monitoring visits for 11 to 16 weeks over the course of the study. At these visits, aggression levels and medication side effects will be assessed. Families will also meet with the researchers to discuss the child's progress and will attend behavioral counseling with a therapist.
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joseph C. Blader, PhD, MSc | 631-632-8317 | joseph.blader@stonybrook.edu |
Contact: Ashley E. Conway, BSc | 631-632-8317 | ashley.conway@stonybrook.edu |
United States, New York | |
Stony Brook University Medical Center | Recruiting |
Stony Brook, New York, United States, 11794-8790 | |
Contact: Ashley E. Conway, BSc 631-632-8317 ashley.conway@stonybrook.edu | |
Principal Investigator: Joseph C. Blader, PhD, MSc | |
North Shore - LIJ Health System, Zucker Hillside Hospital | Recruiting |
Glen Oaks, New York, United States, 11040 | |
Contact: Michele Gonen, BA 718-470-8487 mgonen@nshs.edu | |
Contact: Alison Berest, MA 718-470-8487 aberest@lij.edu | |
Principal Investigator: Vivian Kafantaris, MD | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Denise Molock 210-567-5475 dmolock@uthscsa.edu | |
Principal Investigator: Steven Pliszka, MD |
Principal Investigator: | Joseph C. Blader, PhD, MSc | Stony Brook University School of Medicine, State University of New York |
Responsible Party: | Stony Brook University, State University of New York ( Joseph C. Blader, PhD ) |
Study ID Numbers: | R01 MH080050, DSIR 84-CTM |
Study First Received: | November 19, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00794625 |
Health Authority: | United States: Federal Government |
Attention-Deficit/Hyperactivity Disorder Aggressive Behavior Oppositional Defiant Disorder Conduct Disorder |
Conduct Disorder Risperidone Methylphenidate Attention Deficit and Disruptive Behavior Disorders Valproic Acid Dyskinesias Serotonin Behavioral Symptoms Signs and Symptoms |
Dopamine Oppositional defiant disorder Attention Deficit Disorder with Hyperactivity Mental Disorders Dextroamphetamine Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Aggression |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Enzyme Inhibitors Antipsychotic Agents |
Antimanic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Pathologic Processes Therapeutic Uses GABA Agents Dopamine Agents Central Nervous System Agents Anticonvulsants |