Local clinic to test new ADHD medication

EAST COUNTY — An East County-based research center will be one of six sites nationwide to conduct trials of a new drug aimed at helping children with Attention Deficit Hyperactive Disorder, or ADHD.

The Florida Clinical Research Center has started a clinical study for a new form of extended-release methylphenidate, which is under review by the Federal Food and Drug Administration.

Participating children are ages 6 to 12 and are now in their fifth week of taking the medication. Soon the kids will spend a half-day in a simulated classroom at Woodland Community Church, where specially-trained psychologists — Drs. Conrad Beckles and Amy Parks — will objectively rate their behavior. The doctors will rate the children by observing their behavior while on the medication — from participation in class, such as raising hands, to their focus and attention on math problems.

After the half-day in the classroom, a double-blind handout of a placebo will be given out. In early October, the children will return to the simulated classroom where they will be studied once again. The data will then be collected, compared and sent to the FDA.

The center’s chief medical officer, Dr. Andrew J. Cutler, will conduct the study in a simulated classroom.

“A major benefit is that we’re helping society; until now, there hasn’t been another option for kids who can’t get the medicine in their system,” Cutler said. “It will be the first non-pill form of extended-release medication. Because ADHD can be diagnosed in children as young as 4, having the option to take medication in either a liquid or chewable form allows children to more easily consume it, compared to the traditional form of a pill.”

Unlike most studies in which children are only brought in weekly and go through an evaluation with a doctor, this study will monitor the children on the medication in a school environment, Cutler said.

Traditionally, ADHD is seen as a negative disorder, and many children have been bullied or singled out because of their behavioral tendencies, Cutler said.

“ADHD is neither good nor bad,” Cutler said. “It can be an advantage. Thomas Jefferson, Albert Einstein — they had ADHD.”

Once the study results are sent to the FDA, Cutler plans to continue working with some of the children. The clinic will help find the best medication for each child, he said.

The FLCRC is also gathering a group of teenagers, ages 13 to 17, for additional studies, because that demographic is usually overlooked.

For more information, contact the Florida Clinical Research Center at 747-7900.