May 11, 2011 -- Combining an extended-release version of the blood pressure pill clonidine with a stimulant may benefit children with attention deficit hyperactivity disorder (ADHD) who are not getting adequate relief from stimulants alone, according to a new study.
As many as 5% of children and adults in the U.S. have ADHD, a behavioral disorder marked by impulsiveness, hyperactivity, and inattention. Stimulants are often the first-line therapy, but they can have side effects that include poor appetite and sleeplessness.
Extended-release clonidine is FDA-approved for use alone or with stimulants for children ages 6 to 17 with ADHD. The drug helps boost levels of the brain chemical norepinephrine.
“This combination can benefit those kids who are not showing the best response to stimulants alone or kids who have otherwise intolerable side effects from stimulants and require a lower dose,” says study researcher Scott H. Kollins, PhD, director of the Duke ADHD Program in Durham, N.C. “Kids who don’t respond as well to front-line treatment with stimulants have the potential to get a lot of benefit if we add extended-release clonidine.”
In the eight-week study of 198 adolescents with ADHD, those who received extended-release clonidine in addition to stimulant therapy showed greater reductions in symptoms, compared to those who received a placebo with their stimulant medication.
The study evaluated extended-release clonidine, which provides a more steady dose of medication throughout the day and reduces side effects including low blood pressure and fainting. Previous studies have looked at the immediate-release clonidine.
The findings appear online in Pediatrics.
Clonidine side effects in the new study included sleepiness, headache, fatigue, upper abdominal pain, and nasal congestion. The drug has been linked to cardiovascular side effects including decreased heart rate and a decrease in blood pressure.
“The maximal benefit is achieved if we combine pharmacologic and non-pharmacologic therapies,” Kollins says. Behavioral changes such as set bedtimes and routines are helpful.
“Medications set the stage for learning; that needs to happen to modify behaviors,” he says.
Eric Hollander, MD, a clinical professor of psychiatry and behavioral sciences at Albert Einstein College of Medicine in the Bronx, N.Y., and director of the Compulsive, Impulsive and Autism Spectrum Disorders Program at Montefiore Medical Center, says that many children with ADHD will require more than one medication to get their symptoms under control.
“Many kids may end up on more than one medication and it is a big advantage to have comprehensive data on add-on treatments in this population,” he says.
“ADHD can be a complex disorder characterized by sustained inattention or irritability and impulsivity, and some patients will require combination treatment,” Hollander says. Some research shows that clonidine is helpful with irritability, hyperactivity, and executive function or planning and organization skills.
The best way to determine if your child is getting adequate symptom relief is to communicate with his or her teachers, pediatricians, psychologists, or neurologists, he says. “This can help you get a good sense of whether or not there is adequate benefit from the stimulant alone, what symptom domains seem to be improving, and whether there is room for additional benefit.”
“It’s good to have a tool kit of different kinds of treatments that might be appropriate for different kinds of kids with ADHD,” Hollander says.
Eric Hollander, MD, clinical professor, psychiatry and behavioral sciences, Albert Einstein College of Medicine, Bronx, N.Y.; director, Compulsive, Impulsive and Autism Spectrum Disorders Program, Montefiore Medical Center.
Scott H. Kollins, PhD, director, Duke ADHD Program, Durham, N.C.