A Phase 4 interventional study of Valproate and Risperidone in Attention Deficit Disorder With Hyperactivity, sponsored by Joseph Blader. Status unknown at 3 sites in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2012-07-16.
Sponsored by Joseph Blader · Phase 4, Interventional, and Treatment
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).
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's planned enrollment of 270 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.
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Exclusion Criteria:
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 · Drug: Risperidone · Drug: Stimulant medication · Behavioral: Behavioral family counseling
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 · Drug: Risperidone · Drug: Stimulant medication · Behavioral: Behavioral family counseling
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 · Drug: Stimulant medication · Behavioral: Behavioral family counseling
Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
Also known as: Depakote, Valproic acid
Standard therapeutic doses of risperidone for 8 weeks
Also known as: Risperdal
An inactive substance at identical dosing to active treatments for 8 weeks
Also known as: Inactive substance, "Sugar pill"
Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
Also known as: Ritalin, Dexedrine
Weekly behavioral counseling with a therapist
Aggressive behavior
Time frame: Measured weekly for 11 to 16 weeks
ADHD symptoms
Time frame: Measured weekly for 11 to 16 weeks
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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