Attention-deficit/hyperactivity disorder (ADHD) is characterized by the inability to pay attention, impulsivity and, sometimes, hyperactivity. Researchers estimate the condition affects more than 8 percent of children in the U.S. Symptoms begin by age seven and may last through adulthood.

ADHD is classified into three types. The predominantly inattentive type is marked by problems with attention and organization. Children may have difficulty following instructions, paying attention to details, focusing on assignments, staying organized and finishing a task. This subtype is sometimes referred to as Attention-Deficit Disorder, or ADD. The predominantly hyperactive-impulsive type is characterized by only hyperactivity and impulsive behaviors. Children may have trouble sitting still and may not want to wait to take turns. The combined type includes children who have difficulty with both attention and hyperactivity/impulsivity. Most children with ADHD have the combined type.

ADHD is typically treated with medication, most commonly stimulants, like methylphenidate (Ritalin®, CONCERTA® or Metadate-CD™), amphetamine (Adderall®), or dexmethylphenidate (Focalin®). Some other medications may also be used. Drug therapy may be supplemented with cognitive-behavioral therapy, social skills training, parent education and educational modifications.

A study in the journal, Archives of Pediatrics and Adolescent Medicine, found less than half of all children meeting the diagnostic criteria for ADHD had received a diagnosis or were getting treatment. Untreated, children with ADHD are at higher risk for school failure, problems with peer relationships, depression and substance abuse.

CLONICEL® for ADHD

Clonidine is a medication that’s approved for treatment of high blood pressure. Some physicians prescribe it off-label for patients with ADHD, as an add-on treatment to stimulant medications. Robert Lehman, M.D., Child Psychiatrist with Pharmasite Research, Psychiatric Consultants, says clonidine is helpful in managing some of the side effects of stimulant medication, like insomnia. But clonidine is quickly absorbed into the body, causing fluctuating levels in the bloodstream. After taking clonidine, patients have an immediate spike in blood levels of the drug. In some cases, children experience daytime drowsiness. Then, the effectiveness wears off until the next dose.

Now, doctors are testing a different form of clonidine, called CLONICEL®. CLONICEL is an extended release version of the drug. Once taken, the medication is slowly released throughout the day, providing a consistent level of the drug in a child’s body.

Researchers recently completed a phase III study of CLONICEL in more than 200 children with ADHD whose symptoms could not be adequately controlled with stimulant medication. In the double-blind study, some children got the medication and some got a placebo. All the participants continued to take their regular stimulant medication. Investigators then rated the children on nine measures of hyperactivity and nine measures of attention. The study found the addition of CLONICEL led to a significant improvement in ADHD symptoms compared to a placebo. Since the drug is slowly released into the bloodstream, side effects are minimal.

Researchers are now performing a study to see if CLONICEL is safe as a longer term treatment for children with ADHD. The study is open by invitation only. For information go to http://www.addrenex.com/clinical_trials.html. You can also find information by going to http://www.clinicaltrials.gov, then typing the trial identification number in the search box: NCT00723190.

AUDIENCE INQUIRY For information on CLONICEL®: http://www.addrenex.com/lead_product.html

For information about the study, go to http://www.addrenex.com/clinical_trials.html . You can also find information by going to http://www.clinicaltrials.gov, then typing the trial identification number in the search box: NCT00723190.

For information on ADHD:

American Academy of Child and Adolescent Psychiatry, http://www.aacap.org

Centers for Disease Control and Prevention, http://www.cdc.gov/ncbddd/adhd/default.htm

National Institute of Mental Health, http://www.nimh.nih.gov