Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)
NCT ID: NCT00794625
Last Updated: 2012-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
270 participants
INTERVENTIONAL
2008-11-30
2013-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
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.
Valproate
Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
Risperidone
Standard therapeutic doses of risperidone for 8 weeks
Stimulant medication
Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
Behavioral family counseling
Weekly behavioral counseling with a therapist
2
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.
Valproate
Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
Risperidone
Standard therapeutic doses of risperidone for 8 weeks
Stimulant medication
Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
Behavioral family counseling
Weekly behavioral counseling with a therapist
3
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.
Placebo
An inactive substance at identical dosing to active treatments for 8 weeks
Stimulant medication
Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
Behavioral family counseling
Weekly behavioral counseling with a therapist
Interventions
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Valproate
Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
Risperidone
Standard therapeutic doses of risperidone for 8 weeks
Placebo
An inactive substance at identical dosing to active treatments for 8 weeks
Stimulant medication
Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
Behavioral family counseling
Weekly behavioral counseling with a therapist
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of persistent, clinically significant aggression
* Presence of ODD or CD
Exclusion Criteria
* Presence of a major developmental disability
* Presence of a major mood disorder
* Contraindications to stimulant, valproate, or risperidone treatment
6 Years
12 Years
ALL
No
Sponsors
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University of Texas
OTHER
Northwell Health
OTHER
Joseph Blader
NIH
Responsible Party
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Joseph Blader
Associate Professor of Psychiatry, Stony Brook State University of New York
Principal Investigators
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Joseph C. Blader, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University School of Medicine, State University of New York
Locations
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North Shore - LIJ Health System, Zucker Hillside Hospital
Glen Oaks, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Ingrid S Fuentes, BA
Role: primary
Allison Berest, BA
Role: backup
Lauren M Chorney, PhD
Role: primary
Gabrielle A Carlson, MD
Role: backup
Candy Rhine
Role: primary
Maria Silva
Role: backup
References
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Blader JC, Pliszka SR, Kafantaris V, Foley CA, Carlson GA, Crowell JA, Bailey BY, Sauder C, Daviss WB, Sinha C, Matthews TL, Margulies DM. Stepped Treatment for Attention-Deficit/Hyperactivity Disorder and Aggressive Behavior: A Randomized, Controlled Trial of Adjunctive Risperidone, Divalproex Sodium, or Placebo After Stimulant Medication Optimization. J Am Acad Child Adolesc Psychiatry. 2021 Feb;60(2):236-251. doi: 10.1016/j.jaac.2019.12.009. Epub 2020 Jan 30.
Blader JC, Pliszka SR, Kafantaris V, Sauder C, Posner J, Foley CA, Carlson GA, Crowell JA, Margulies DM. Prevalence and Treatment Outcomes of Persistent Negative Mood Among Children with Attention-Deficit/Hyperactivity Disorder and Aggressive Behavior. J Child Adolesc Psychopharmacol. 2016 Mar;26(2):164-73. doi: 10.1089/cap.2015.0112. Epub 2016 Jan 8.
Blader JC, Pliszka SR, Kafantaris V, Foley CA, Crowell JA, Carlson GA, Sauder CL, Margulies DM, Sinha C, Sverd J, Matthews TL, Bailey BY, Daviss WB. Callous-unemotional traits, proactive aggression, and treatment outcomes of aggressive children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2013 Dec;52(12):1281-93. doi: 10.1016/j.jaac.2013.08.024. Epub 2013 Sep 25.
Other Identifiers
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DSIR 84-CTM
Identifier Type: -
Identifier Source: secondary_id