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

Information source: National Institute of Mental Health (NIMH)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity

Intervention: Valproate (Drug); Risperidone (Drug); Placebo (Drug); Stimulant medication (Drug); Behavioral family counseling (Behavioral)

Phase: Phase 4

Status: Recruiting

Sponsored by: Joseph Blader

Official(s) and/or principal investigator(s):
Joseph C. Blader, PhD, MSc, Principal Investigator, Affiliation: Stony Brook University School of Medicine, State University of New York

Overall contact:
Joseph C. Blader, PhD, MSc, Phone: 631-632-8317, Email: joseph.blader@stonybrook.edu

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).

Clinical Details

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

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

Primary outcome: Aggressive behavior

Secondary outcome: ADHD symptoms

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

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

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

Locations and Contacts

Joseph C. Blader, PhD, MSc, Phone: 631-632-8317, Email: joseph.blader@stonybrook.edu

North Shore - LIJ Health System, Zucker Hillside Hospital, Glen Oaks, New York 11040, United States; Recruiting
Ingrid S Fuentes, BA, Phone: 718-470-8487, Email: isfuentes@nshs.edu
Allison Berest, BA, Phone: 718-470-8868, Email: nkatsiot@nshs.edu
Vivian Kafantaris, MD, Principal Investigator

Stony Brook University Medical Center, Stony Brook, New York 11794-8790, United States; Recruiting
Lauren M Chorney, PhD, Phone: 631-632-8317, Email: lauren.chorney@stonybrook.edu
Gabrielle A Carlson, MD, Phone: (631) 632-8842, Email: gabrielle.carlson@stonybrook.edu
Joseph C. Blader, PhD, MSc, Principal Investigator

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States; Recruiting
Candy Rhine, Phone: 210-614-7070, Ext: 250, Email: rhine@uthscsa.edu
Maria Silva, Phone: (210) 614-7070, Ext: 251, Email: maria@cgcsanantonio.org
Steven Pliszka, MD, Principal Investigator
Thomas L. Matthews, M.D., Sub-Investigator

Additional Information

Starting date: November 2008
Last updated: July 13, 2012

Page last updated: August 20, 2015

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