Prescribing powerful antipsychotic medications to children with behavioral problems is controversial. Little is known about the long-term safety of these medications, which are approved by the U.S. Food and Drug Administration to treat severe mental illnesses such as schizophrenia and bipolar disorder. And previous studies have provided little evidence to support the idea that they help quell youngsters' violent outbursts.
But the new study, which was published online in the January issue of the Journal of the American Academy of Child and Adolescent Psychiatry, suggests there might be some merit to the idea, at least for severely troubled kids.
The study looked at a subset of children with ADHD who also are physically violent, meaning they're either destructive or aggressive toward themselves or others, the researchers said.
"The children who participated in this trial had far more significant behavioral issues than the typical child with ADHD alone," said study author Michael Aman, director of clinical trials at Ohio State University's Nisonger Center.
"These are children who are really in conflict with their communities and their families," Aman said. "They seem to be in a spiral they can't get out of."
The 168 children in the study were between 6 and 12 years old with a diagnosis of ADHD and oppositional-defiant disorder or conduct disorder. All had displayed recent episodes of serious physical aggression in which they destroyed property or, at a minimum, left bruises on themselves or others.
All were started on a stimulant medication -- typically long-acting methylphenidate (sold under the brand name Concerta), which is a common treatment for ADHD. Their parents got special training in how to manage impulsive behaviors.
After three weeks, those who had not been helped enough by the basic measures were allowed to start a second medication, which was assigned at the start of the study. Sixty-one kids who started the second medication took the antipsychotic risperidone (Risperdal) for six more weeks, while 69 children continued basic treatment and got an added placebo pill.
After nine weeks, children who took Risperdal in addition to their stimulant medication saw modest but significant improvements in behavior compared to those who continued on the stimulant by itself.
"I don't think it's a grand slam, but I do think it indicates that there is some justification for what doctors have begun to do, which is to combine treatment," Aman said.
Aman said the average improvement on Risperdal was moderate. "Buried in that moderate are kids who did much better, kids who did somewhat better and some kids who didn't do better at all," he said.
Aman said scientists really need to look more closely to understand why some children had big improvements with the addition of Risperdal while others got no further help.
In some cases, Risperdal seemed to cancel some of the most bothersome side effects of the stimulants, including loss of appetite and trouble falling asleep.
But Aman cautioned that antipsychotics must always be prescribed with great care since they cause weight gain and increase the risk for type 2 diabetes.
The study was sponsored by a grant from the U.S. National Institute of Mental Health.
About half of children with ADHD who are referred for psychiatric help have behavioral disorders as well as ADHD, according to the U.S. Centers for Disease Control and Prevention.
An expert who was not involved in the research praised the study and said it would help doctors sort out what is often a tricky treatment decision.
In kids with ADHD and aggressive behavior, "recent guidelines say you should try to treat the ADHD first," said Joseph Blader, an associate professor at the University of Texas Health Science Center at San Antonio. "Then the issue is, how long do you spend doing that if the child is having these explosions, these meltdowns, potentially hurting people, on the threshold of getting kicked out of school? Two weeks? Three weeks?"
Blader said that, because so many of the kids in the study's placebo group continued to improve on the stimulant medication alone, doctors might be justified in waiting a few more weeks to see if the aggression improves along with the ADHD.
"I think this study shows that you get a lot of bang for your buck with stimulants and parent training," he said. "Unless it's a very extreme situation, it's optimal to let those play out [before trying a second medication]."