Attention Deficit Disorder With Hyperactivity | Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)
Attention Deficit Disorder With Hyperactivity research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Attention Deficit Disorder With Hyperactivity
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:ValproateStandard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
Drug:RisperidoneStandard therapeutic doses of risperidone for 8 weeks
Drug:PlaceboAn inactive substance at identical dosing to active treatments for 8 weeks
Drug:Stimulant medicationStimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
Behavioral:Behavioral family counselingWeekly behavioral counseling with a therapist
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1During 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.
2During 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.
3During 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.
Start Date: November 2008
Completed Date: April 2013
Phase: Phase 4
Primary Outcome: Aggressive behavior
Secondary Outcome: ADHD symptoms
Study sponsors, principal investigator, and references
Principal Investigator: Joseph C. Blader, PhD, MSc
Lead Sponsor: Joseph Blader
Collaborator: University of Texas