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

July 13, 2012 updated by: Joseph Blader

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Glen Oaks, New York, United States, 11040
        • Recruiting
        • North Shore - LIJ Health System, Zucker Hillside Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vivian Kafantaris, MD
      • Stony Brook, New York, United States, 11794-8790
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Contact:
        • Principal Investigator:
          • Steven Pliszka, MD
        • Sub-Investigator:
          • Thomas L. Matthews, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Risperdal
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: 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.
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 Names:
  • Risperdal
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
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.
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
Drug: Placebo
An inactive substance at identical dosing to active treatments for 8 weeks
Other Names:
  • Inactive substance
  • "Sugar pill"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aggressive behavior
Time Frame: Measured weekly for 11 to 16 weeks
Measured weekly for 11 to 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ADHD symptoms
Time Frame: Measured weekly for 11 to 16 weeks
Measured weekly for 11 to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph Blader

Collaborators

Northwell Health
University of Texas

Investigators

  • Principal Investigator: Joseph C. Blader, PhD, MSc, Stony Brook University School of Medicine, State University of New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (Estimate)

November 20, 2008

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 13, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH080050 (U.S. NIH Grant/Contract)
  • DSIR 84-CTM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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