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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Attention Deficit Disorder With Hyperactivity

In brief

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).

Key facts

Study ID

NCT00794625

Run by

Joseph Blader

People needed

270

Starts

2008-11-01

Expected to finish

2013-04-01

Last updated by the study team

2012-07-16

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of ADHD
• Presence of persistent, clinically significant aggression
• Presence of ODD or CD

You may not qualify if…

• Presence of psychosis
• Presence of a major developmental disability
• Presence of a major mood disorder
• Contraindications to stimulant, valproate, or risperidone treatment

Where it is running

• North Shore - LIJ Health System, Zucker Hillside Hospital — Glen Oaks, New York, United States (enrolling)
• Stony Brook University Medical Center — Stony Brook, New York, United States (enrolling)
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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