Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)
Study Details
Study Description
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 hyperactivity disorder (ADHD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 During 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. |
Drug: Valproate
Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
Other Names:
Drug: Risperidone
Standard therapeutic doses of risperidone for 8 weeks
Other Names:
Drug: Stimulant medication
Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
Other Names:
Behavioral: Behavioral family counseling
Weekly behavioral counseling with a therapist
|
| Experimental: 2 During 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. |
Drug: Valproate
Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
Other Names:
Drug: Risperidone
Standard therapeutic doses of risperidone for 8 weeks
Other Names:
Drug: Stimulant medication
Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
Other Names:
Behavioral: Behavioral family counseling
Weekly behavioral counseling with a therapist
|
| Placebo Comparator: 3 During 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. |
Drug: Placebo
An inactive substance at identical dosing to active treatments for 8 weeks
Other Names:
Drug: Stimulant medication
Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
Other Names:
Behavioral: Behavioral family counseling
Weekly behavioral counseling with a therapist
|
Outcome Measures
Primary Outcome Measures
- Aggressive behavior [Measured weekly for 11 to 16 weeks]
Secondary Outcome Measures
- ADHD symptoms [Measured weekly for 11 to 16 weeks]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- Joseph Blader
- University of Texas
- Northwell Health
Investigators
- Principal Investigator: Joseph C. Blader, PhD, MSc, Stony Brook University School of Medicine, State University of New York
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01MH080050
- DSIR 84-CTM