New Study Confirms CONCERTA Efficacy and Safety in Adolescents

Thursday, December 8th, 2011

ADHD Symptoms, Parent-Child Conflict Significantly Improved with Treatment

SAN FRANCISCO, Oct. 24 /PRNewswire/ — One of the largest studies to date on the use of a stimulant medication by teenagers confirms the effectiveness and safety of CONCERTA(R) (methylphenidate HCl) Cll for adolescents with attention deficit/hyperactivity disorder (ADHD). The findings were presented today at a national meeting of child and adolescent psychiatrists.

In the study, teenagers taking a daily dose of CONCERTA saw their ADHD symptoms such as inattention, hyperactivity, and impulsivity, significantly improve. Researchers also reported less conflict within the family between teens and their parents/caregivers.

“Emotional changes and behavioral outbursts, which can occur during adolescence, are even more common when ADHD is present,” said Larry Greenhill, M.D., Professor of Clinical Psychiatry, New York State Psychiatric Institute, and one of the study’s investigators. “In this study, parents reported that teens diagnosed with ADHD engaged in significantly less conflict-driven behavior on Concerta compared to placebo.”

Although it is the most common neurobehavioral disorder in children, ADHD in adolescents has not been widely studied. Research shows that as many as 80 percent of children with ADHD exhibit persistent symptoms during adolescence, and 65 percent go on to display symptoms during adulthood. Left untreated, many teenagers with ADHD suffer academic impairment, driving-related incidents, and are also at risk of substance abuse, increased levels of antisocial activity, encounters with law-enforcement, and consequent negative impact within the family.

“Overall, Concerta produced statistically significant improvements in ADHD core symptoms and was significantly superior to placebo on all efficacy measures in this adolescent population,” noted Dr. Greenhill. “The data also suggests that daily doses higher than 54mg may be warranted in older age groups particularly when symptoms of ADHD are not responding to lower doses of medication.”

About the Study

A total of 177 adolescents, ages 13 through 18 participated in this multi-center, randomized, double blind study. All participants had a confirmed diagnosis of ADHD. Subjects who met the entry criteria and were already taking an ADHD medication discontinued therapy for one week to establish baseline evaluations. The study then consisted of two stages: an open-label titration period followed by a randomized, double blind phase. An ongoing open-label follow-up phase is currently underway.

All subjects initiated treatment with an 18mg once-daily dose of CONCERTA for a period of one week. Dosage was increased weekly in 18mg increments as needed to a maximum of 72mg a day (given as two 36mg tablets once a day). A subject was considered to have completed the titration phase upon reaching the dose that produced a pre-determined optimal improvement of his/her ADHD symptoms from baseline. Upon reaching this level, subjects were then eligible for randomization to receive either their established individualized CONCERTA dose or placebo.

During the two-week randomized, double blind phase of the study, subjects received either their individualized once-daily dose of CONCERTA (18, 36, 54, or 72mg) or placebo. At the end of each week, each teen’s behavior and attention were assessed over the previous week using standard rating scales completed by investigators, parents/caregivers, and the adolescents themselves. Twice a week, parents/caregivers provided researchers with information pertaining to levels of conflict (i.e., misbehavior, fighting, arguments) and negativity (i.e., passiveness, depression, foul language) they observed or perceived in their teenage child.

Beginning at baseline and during each week of the randomized, double blind phase, teenagers also filled out a self-report questionnaire, which provided investigators with individuals’ self-assessments about the effect of treatment on ADHD symptoms (i.e., attention, behavior), impact on relationships with family and friends, and feelings.

“An adolescent’s sense of improvement or non-improvement affects their self-esteem,” explained Dr. Greenhill. “Overall, teenagers self-reported a statistically significant difference between Concerta and placebo, noting that the once-a-day medication helped them manage their ADHD symptoms, enabling them to stay more focused and under control.”

Subjects who completed the double-blind phase were eligible to enter an eight-week open-label phase. Study participants who discontinued the double- blind phase early for whatever reason were also able to enroll in the open- label follow-up. Virtually all of these subjects entered the open-label phase and opted for treatment with CONCERTA at their individualized optimal dose. This phase of the study is still ongoing.

The type and frequency of adverse events in this study were consistent with previously controlled studies of CONCERTA. There were no unusual or unexpected adverse events.


CONCERTA is an extended-release formulation of methylphenidate for ADHD treatment that is designed to last through 12 hours, with just one morning dose. Concerta uses an advanced OROS(R) extended-release delivery system. The OROS(R) trilayer tablet is designed to release the medication in CONCERTA in a controlled pattern providing symptom management throughout the day. 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 was approved by the U.S. Food and Drug Administration in 2000. It is marketed in the United States by McNeil Consumer & Specialty Pharmaceuticals. For more information about CONCERTA, call 1-888-440-7903 or visit