- Psychological Issues
In the first study to compare the effects of ADHD medications on driving performance, teens with attention deficit/hyperactivity disorder who took the once-daily medication Concerta (methylphenidate HCl) CII, demonstrated better speed control, used their brakes more appropriately, and were better able to obey traffic signals than when they took a commonly prescribed treatment for the disorder, methylphenidate given three times a day.
“The findings suggest that this once-a-day medication may lessen the risk of accidents for drivers with ADHD,” noted the study’s lead investigator Daniel Cox, Ph.D., Professor of Psychiatric Medicine and Director, Behavioral Medicine Center at the University of Virginia Health System. “When taking the medication once in the morning, teenagers demonstrated significantly less variability in driving performance, performed significantly better throughout the day, and reported that they took fewer driving risks.” The study was presented at a national meeting of child and adolescent psychiatrists.
According to the American Automobile Association, teenagers account for only seven percent of all drivers, yet they are involved in 14 percent of all fatal auto accidents and 20 percent of all accidents. research also shows that young drivers with attention deficit/hyperactivity disorder are two to four times more likely to have a motor vehicle accident; are more than three times as likely to be injured, and are four times more likely to be at fault for such accidents compared to young drivers without ADHD.
Using a combination of real-world driving experience and state-of-the-art driving simulation, the study compared the effect on driving performance following a single morning dose of Concerta, or short-acting methylphenidate, given three times a day. Concerta is the only osmotic, controlled-release OROS formulation of methylphenidate that controls ADHD symptoms effectively through 12 hours.
Driving performance remained stable throughout the day when participants received the once-daily medication. But it worsened throughout the day — with a sharp decline at 8:00 p.m. — when they received methylphenidate three times a day. Additionally, when teenagers took the three-times-a-day treatment they tended to have more high-speed collisions, less steering control, and ignored more stop signals.
“Driving is a complex activity that places demands on the attentional and executive function processes of anyone, but particularly for individuals with ADHD,” commented David Goodman, M.D., Assistant Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University and Director of the Adult Attention Deficit Disorder Center of Maryland. “Drivers must organize, plan and modify activity; hold, process, and manipulate information; and monitor the appropriateness of their ongoing responses. The improved driving performance and attentiveness of teenage drivers treated with Concerta may be due to the medication’s advanced OROS extended-release delivery system, which delivers a controlled rate of medication throughout the entire day, not just during work or school hours.”
According to the National Center for Health Statistics, motor vehicle accidents are the leading cause of death for teenagers. Studies conducted for the National Highway Traffic Safety Administration (NHTSA) indicate the presence of ADHD contributes significantly to this statistic and that failure to obey traffic signals or officer directions accounts for one in five fatal crashes.
Adolescents with ADHD are more likely to engage in risky driving behaviors that merit the attention of law enforcement. They are two to six times more likely to be given speeding violations, receive four to five times the number of violations, and are six to eight times more likely to have their license suspended than comparable young drivers without ADHD.
The impact of ADHD on driving is not limited to boys. Scientific studies have also found that ADHD is significantly associated with increased risk for traffic accidents and traffic convictions in females.
This randomized crossover study compared once-daily Concerta and methylphenidate given three times a day on sustained driving performance of six male adolescents, aged 16 to19, with documented ADHD. Participants stayed on each medication for seven days after their optimal dose was determined. On the seventh day of each medication participants completed computer-simulated driving courses at 2:00 p.m., 5:00 p.m., 8:00 p.m., and 11:00 p.m.
Impaired Driving Scores (IDS) were calculated using data from the Atari research Driving Simulator, which were recorded eight times per second on nine measures of steering control, braking ability and speed control. The simulators have been used in numerous other studies to document the impact on driving of various conditions such as Alzheimer’s disease, intoxication and hypoglycemia. Subjects also completed a daily driving diary regarding their risky driving practices and driving errors. The study’s methodology yielded nearly four million data points.
“We were surprised to find such robust and highly significant results with six subjects,” explained Dr. Cox. “Scientific studies typically require larger numbers of patients to reach such statistically valid findings.” The study was sponsored by McNeil Consumer & Specialty Pharmaceuticals, U.S. marketers of Concerta.
ADHD is the most common psychiatric disorder among children. Two new reports from the Mayo Clinic and the Centers for Disease Control estimate that approximately seven percent of children suffer from the disorder. As many as 80 percent of ADHD-diagnosed children continue to suffer from the disorder as adolescents. Methylphenidate has been used to treat ADHD safely and effectively for more than 60 years. Up to 90 percent of individuals with ADHD respond positively to stimulant medication.
Concerta, taken once a day, is an integral part of a total ADHD treatment program. Concerta uses an advanced OROS extended-release delivery system to deliver a controlled rate of medication throughout the day. The OROS trilayer tablet is designed to release the medication in Concerta in a smoothly delivered pattern maintaining improved attention and behavior through 12 hours, including during activities outside of school or work.
Because of its unique OROS system, Concerta minimizes the ups and downs in blood levels experienced with stimulant medications taken several times a day. research confirms that a single dose of Concerta is as effective as the standard three-times-a-day dosing regimen of methylphenidate, the most commonly prescribed medication for ADHD.
Concerta also eliminates the need for dosing in and out of school or work, since it is taken once in the morning (with or without food). This is especially important for patients who participate in academic, job-related, or social activities outside of school or work.
Concerta should not be taken by patients who: have significant anxiety, tension, or agitation, since Concerta may make these conditions worse; are allergic to methylphenidate or any of the other ingredients in Concerta; have glaucoma, an eye disease; have tics or Tourette’s syndrome, or a family history of Tourette’s syndrome; are taking a prescription monoamine oxidase inhibitor (MAOI). Concerta should not be administered to patients with preexisting severe gastrointestinal narrowing. Concerta should not be used in children under six years, since safety and efficacy in this age group have not been established.
Concerta should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence. (See Boxed Warning in the full U.S. Prescribing Information for Concerta).
CONCERTA is marketed in the United States by McNeil Consumer & Specialty Pharmaceuticals. For more information about CONCERTA, including full U.S. Prescribing Information, call 1-888-440-7903 or visit www.concerta.net.
Courtesy of ARA Content