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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
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
  Purpose

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).


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: Valproate
Drug: Risperidone
Drug: Placebo
Drug: Stimulant medication
Behavioral: Behavioral family counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Treatment With Divalproex or Risperidone for Aggression Refractory to Stimulant Monotherapy Among Children With ADHD

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Aggressive behavior [ Time Frame: Measured weekly for 11 to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADHD symptoms [ Time Frame: Measured weekly for 11 to 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: November 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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: 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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794625

Contacts
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

Locations
United States, New York
North Shore - LIJ Health System, Zucker Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11040
Contact: Ingrid S Fuentes, BA    718-470-8487    isfuentes@nshs.edu   
Contact: Allison Berest, BA    718-470-8868    nkatsiot@nshs.edu   
Principal Investigator: Vivian Kafantaris, MD         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794-8790
Contact: Lauren M Chorney, PhD    631-632-8317    lauren.chorney@stonybrook.edu   
Contact: Gabrielle A Carlson, MD    (631) 632-8842    gabrielle.carlson@stonybrook.edu   
Principal Investigator: Joseph C. Blader, PhD, MSc         
United States, Texas
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Candy Rhine    210-614-7070 ext 250    rhine@uthscsa.edu   
Contact: Maria Silva    (210) 614-7070 ext 251    maria@cgcsanantonio.org   
Principal Investigator: Steven Pliszka, MD         
Sub-Investigator: Thomas L. Matthews, M.D.         
Sponsors and Collaborators
Joseph Blader
University of Texas
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Joseph C. Blader, PhD, MSc Stony Brook University School of Medicine, State University of New York
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Blader, Associate Professor of Psychiatry, Stony Brook State University of New York, National Institute of Mental Health
ClinicalTrials.gov Identifier: NCT00794625     History of Changes
Other Study ID Numbers: R01 MH080050, DSIR 84-CTM
Study First Received: November 19, 2008
Last Updated: July 13, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Attention-Deficit/Hyperactivity Disorder
Aggressive Behavior
Oppositional Defiant Disorder
Conduct Disorder

Additional relevant MeSH terms:
Aggression
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Behavioral Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Valproic Acid
Risperidone
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents

ClinicalTrials.gov processed this record on July 22, 2014