Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)

This study is currently recruiting participants.
Verified July 2012 by National Institute of Mental Health (NIMH)
Sponsor:
Collaborators:
University of Texas
North Shore Long Island Jewish Health System
Information provided by (Responsible Party):
Joseph Blader, National Institute of Mental Health
ClinicalTrials.gov Identifier:
NCT00794625
First received: November 19, 2008
Last updated: July 13, 2012
Last verified: July 2012

November 19, 2008
July 13, 2012
November 2008
November 2012   (final data collection date for primary outcome measure)
Aggressive behavior [ Time Frame: Measured weekly for 11 to 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00794625 on ClinicalTrials.gov Archive Site
ADHD symptoms [ Time Frame: Measured weekly for 11 to 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
  • Drug: Valproate
    Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
    Other Names:
    • Depakote
    • Valproic acid
  • Drug: Risperidone
    Standard therapeutic doses of risperidone for 8 weeks
    Other Name: Risperdal
  • Drug: Placebo
    An inactive substance at identical dosing to active treatments for 8 weeks
    Other Names:
    • Inactive substance
    • "Sugar pill"
  • Drug: Stimulant medication
    Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
    Other Names:
    • Ritalin
    • Dexedrine
  • Behavioral: Behavioral family counseling
    Weekly behavioral counseling with a therapist
  • Experimental: 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.
    Interventions:
    • Drug: Valproate
    • Drug: Risperidone
    • Drug: Stimulant medication
    • Behavioral: Behavioral family counseling
  • Experimental: 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.
    Interventions:
    • Drug: Valproate
    • Drug: Risperidone
    • Drug: Stimulant medication
    • Behavioral: Behavioral family counseling
  • Placebo Comparator: 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.
    Interventions:
    • Drug: Placebo
    • Drug: Stimulant medication
    • Behavioral: Behavioral family counseling
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
April 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of ADHD
  • Presence of persistent, clinically significant aggression
  • Presence of ODD or CD

Exclusion Criteria:

  • Presence of psychosis
  • Presence of a major developmental disability
  • Presence of a major mood disorder
  • Contraindications to stimulant, valproate, or risperidone treatment
Both
6 Years to 12 Years
No
Contact: Joseph C. Blader, PhD, MSc 631-632-8317 joseph.blader@stonybrook.edu
Contact: Lauren M. Chorney, PhD 631-632-8317 lauren.chorney@stonybrook.edu
United States
 
NCT00794625
R01 MH080050, DSIR 84-CTM
Yes
Joseph Blader, National Institute of Mental Health
Joseph Blader
  • University of Texas
  • North Shore Long Island Jewish Health System
Principal Investigator: Joseph C. Blader, PhD, MSc Stony Brook University School of Medicine, State University of New York
National Institute of Mental Health (NIMH)
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP