Status:
UNKNOWN
Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)
Lead Sponsor:
Joseph Blader
Collaborating Sponsors:
University of Texas
Northwell Health
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief 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...
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 exerc...
Eligibility Criteria
Inclusion
- Presence of ADHD
- Presence of persistent, clinically significant aggression
- Presence of ODD or CD
Exclusion
- Presence of psychosis
- Presence of a major developmental disability
- Presence of a major mood disorder
- Contraindications to stimulant, valproate, or risperidone treatment
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00794625
Start Date
November 1 2008
End Date
April 1 2013
Last Update
July 16 2012
Active Locations (3)
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1
North Shore - LIJ Health System, Zucker Hillside Hospital
Glen Oaks, New York, United States, 11040
2
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-8790
3
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229