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Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Oppositional Defiant Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Divalproex Sodium
Methylphenidate
Dextroamphetamine
Mixed Amphetamine Salts
Family Counseling
Behavior Management Training with Parents
Sponsored by
Stony Brook University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, ODD, Conduct Disorder, CD

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of ADHD Diagnosis of opposition defiant disorder or conduct disorder Score that exceeds the study threshhold on the standardized scale of aggressive behavior Exclusion Criteria: Current psychosis Current major depression Current pervasive developmental disorder Current obsessive compulsive disorder Any other anxiety disorder as primary diagnosis Mental retardation

Sites / Locations

  • Long Island Jewish Medical Center / Schneider Children's Hospital
  • Stony Brook University Hospital

Outcomes

Primary Outcome Measures

Aggression (Measured by the Overt Aggression Scale after 8 weeks of treatment)
Improvement of ADHD symptoms (Measured by the Clinical Global Improvement Scale and ADHD Rating Scale after 8 weeks of treatment)

Secondary Outcome Measures

Full Information

First Posted
September 26, 2005
Last Updated
October 29, 2013
Sponsor
Stony Brook University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00228046
Brief Title
Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder
Official Title
Double-Blind, Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stony Brook University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with attention deficit hyperactivity disorder (ADHD).
Detailed Description
ADHD is one of the most common childhood mental disorders. It often causes impaired functioning in multiple areas, including home, school, and peer relationships. Additionally, children with ADHD often develop aggressive behavior, which is not usually adequately suppressed by standard stimulant treatments for ADHD. In order to address this problem, many physicians prescribe multiple medications at once. There is no clinical evidence, however, proving that this method is safe and effective. This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with ADHD. Participants in this double blind study will first receive open label stimulant treatment for ADHD and a comorbid disruptive behavior disorder. Participants whose aggressive behavior subsides with stimulant treatment alone will not proceed into the next phase of the study. Participants whose ADHD symptoms lessen from the treatment but whose aggressive behavior persists will be randomly assigned to receive either divalproex sodium or placebo in addition to their stimulant treatment for 8 weeks. Study visits will be held weekly for 11 to 16 weeks. 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 attend behavioral counseling with a therapist. Participants who did not continue into the second phase of the study will be asked to return to the study site for a follow-up visit 8 weeks following the end of the first phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Oppositional Defiant Disorder
Keywords
ADHD, ODD, Conduct Disorder, CD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Divalproex Sodium
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Intervention Type
Drug
Intervention Name(s)
Dextroamphetamine
Intervention Type
Drug
Intervention Name(s)
Mixed Amphetamine Salts
Intervention Type
Behavioral
Intervention Name(s)
Family Counseling
Intervention Type
Behavioral
Intervention Name(s)
Behavior Management Training with Parents
Primary Outcome Measure Information:
Title
Aggression (Measured by the Overt Aggression Scale after 8 weeks of treatment)
Title
Improvement of ADHD symptoms (Measured by the Clinical Global Improvement Scale and ADHD Rating Scale after 8 weeks of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of ADHD Diagnosis of opposition defiant disorder or conduct disorder Score that exceeds the study threshhold on the standardized scale of aggressive behavior Exclusion Criteria: Current psychosis Current major depression Current pervasive developmental disorder Current obsessive compulsive disorder Any other anxiety disorder as primary diagnosis Mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph C. Blader, PhD, MSc
Organizational Affiliation
Stony Brook State University of New York School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island Jewish Medical Center / Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8790
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26745211
Citation
Blader JC, Pliszka SR, Kafantaris V, Sauder C, Posner J, Foley CA, Carlson GA, Crowell JA, Margulies DM. Prevalence and Treatment Outcomes of Persistent Negative Mood Among Children with Attention-Deficit/Hyperactivity Disorder and Aggressive Behavior. J Child Adolesc Psychopharmacol. 2016 Mar;26(2):164-73. doi: 10.1089/cap.2015.0112. Epub 2016 Jan 8.
Results Reference
derived
PubMed Identifier
24290461
Citation
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.
Results Reference
derived
PubMed Identifier
19884222
Citation
Blader JC, Schooler NR, Jensen PS, Pliszka SR, Kafantaris V. Adjunctive divalproex versus placebo for children with ADHD and aggression refractory to stimulant monotherapy. Am J Psychiatry. 2009 Dec;166(12):1392-401. doi: 10.1176/appi.ajp.2009.09020233. Epub 2009 Nov 2.
Results Reference
derived

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Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder

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