Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)
Adjunctive Treatment With Divalproex or Risperidone for Aggression Refractory to Stimulant Monotherapy Among Children With ADHD
2 other identifiers
interventional
270
1 country
3
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2008
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 19, 2008
CompletedFirst Posted
Study publicly available on registry
November 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJuly 16, 2012
July 1, 2012
4 years
November 19, 2008
July 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Aggressive behavior
Measured weekly for 11 to 16 weeks
Secondary Outcomes (1)
ADHD symptoms
Measured weekly for 11 to 16 weeks
Study Arms (3)
1
EXPERIMENTALDuring 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.
2
EXPERIMENTALDuring 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.
3
PLACEBO COMPARATORDuring 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.
Interventions
Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
An inactive substance at identical dosing to active treatments for 8 weeks
Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
Eligibility Criteria
You may qualify if:
- Presence of ADHD
- Presence of persistent, clinically significant aggression
- Presence of ODD or CD
You may not qualify if:
- Presence of psychosis
- Presence of a major developmental disability
- Presence of a major mood disorder
- Contraindications to stimulant, valproate, or risperidone treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph Bladerlead
- University of Texascollaborator
- Northwell Healthcollaborator
Study Sites (3)
North Shore - LIJ Health System, Zucker Hillside Hospital
Glen Oaks, New York, 11040, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794-8790, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Related Publications (3)
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.
PMID: 32007604DERIVEDBlader 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.
PMID: 26745211DERIVEDBlader 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.
PMID: 24290461DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph C. Blader, PhD, MSc
Stony Brook University School of Medicine, State University of New York
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry, Stony Brook State University of New York
Study Record Dates
First Submitted
November 19, 2008
First Posted
November 20, 2008
Study Start
November 1, 2008
Primary Completion
November 1, 2012
Study Completion
April 1, 2013
Last Updated
July 16, 2012
Record last verified: 2012-07