Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder

Stony Brook University

Status and phase

Completed

Phase 4

Conditions

Oppositional Defiant Disorder

Attention Deficit Disorder With Hyperactivity

Conduct Disorder

Treatments

Behavioral: Family Counseling

Drug: Divalproex Sodium

Behavioral: Behavior Management Training with Parents

Drug: Methylphenidate

Drug: Mixed Amphetamine Salts

Drug: Dextroamphetamine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00228046

M01RR010710 (U.S. NIH Grant/Contract)

DSIR CT-M1

K23MH064975 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with attention deficit hyperactivity disorder (ADHD).

Full description

ADHD is one of the most common childhood mental disorders. It often causes impaired functioning in multiple areas, including home, school, and peer relationships. Additionally, children with ADHD often develop aggressive behavior, which is not usually adequately suppressed by standard stimulant treatments for ADHD. In order to address this problem, many physicians prescribe multiple medications at once. There is no clinical evidence, however, proving that this method is safe and effective. This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with ADHD.

Participants in this double blind study will first receive open label stimulant treatment for ADHD and a comorbid disruptive behavior disorder. Participants whose aggressive behavior subsides with stimulant treatment alone will not proceed into the next phase of the study. Participants whose ADHD symptoms lessen from the treatment but whose aggressive behavior persists will be randomly assigned to receive either divalproex sodium or placebo in addition to their stimulant treatment for 8 weeks. Study visits will be held weekly for 11 to 16 weeks. 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 attend behavioral counseling with a therapist. Participants who did not continue into the second phase of the study will be asked to return to the study site for a follow-up visit 8 weeks following the end of the first phase.

Enrollment

40 estimated patients

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of ADHD
Diagnosis of opposition defiant disorder or conduct disorder
Score that exceeds the study threshhold on the standardized scale of aggressive behavior

Exclusion criteria