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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Adjunctive Treatment With Divalproex or Risperidone for Aggression Refractory to Stimulant Monotherapy Among Children With ADHD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00794625
• Other study ID #: R01MH080050
• Secondary ID: DSIR 84-CTM
• Status: Recruiting
• Phase: Phase 4
• First received: November 19, 2008
• Last updated: July 13, 2012
• Start date: November 2008
• Est. completion date: April 2013

Study information

• Verified date: July 2012
• Source: National Institute of Mental Health (NIMH)
• Contact: Joseph C. Blader, PhD, MSc
• Phone: 631-632-8317
• Email: joseph.blader[@]stonybrook.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: April 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis

Intervention

Drug:
• 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:
• Behavioral family counseling
Weekly behavioral counseling with a therapist

Locations

Country	Name	City	State
United States	North Shore - LIJ Health System, Zucker Hillside Hospital	Glen Oaks	New York
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (3)

Lead Sponsor	Collaborator
Joseph Blader	Northwell Health, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aggressive behavior		Measured weekly for 11 to 16 weeks	No
Secondary	ADHD symptoms		Measured weekly for 11 to 16 weeks	No