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

Joseph Blader

Status and phase: Unknown; Phase 4

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Placebo; Drug: Stimulant medication; Drug: Valproate; Behavioral: Behavioral family counseling; Drug: Risperidone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00794625

DSIR 84-CTM

R01MH080050

Details and patient eligibility

About

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).

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

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.

Treatment:

Drug: Risperidone

Behavioral: Behavioral family counseling

Drug: Stimulant medication

Drug: Valproate

2

Experimental group

Description:

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.

Treatment:

Drug: Risperidone

Behavioral: Behavioral family counseling

Drug: Stimulant medication

Drug: Valproate

3

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Behavioral family counseling

Drug: Stimulant medication

Drug: Placebo