Concerta (Methylphenidate Hydrochloride) - Summary

CONCERTA SUMMARY

CONCERTA® is a central nervous system (CNS) stimulant.

CONCERTA® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of CONCERTA® in the treatment of ADHD was established in three controlled trials of children aged 6 to 12 who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY).

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, eg, in social, academic, or occupational functioning, and be present in two or more settings, eg, school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics.

CONCERTA® is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

The effectiveness of CONCERTA® for long-term use, ie, for more than 4 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use CONCERTA® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

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CONCERTA NEWS HIGHLIGHTS

Published Studies Related to Concerta (Methylphenidate)

Association Between Homozygosity of a G Allele of the Alpha-2a-Adrenergic Receptor Gene and Methylphenidate Response in Korean Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. [2009.01.14]
BACKGROUND: Methylphenidate [generic for Concerta] (MPH) blocks the norepinephrine transporter as well as the dopamine transporter. The alpha-2a-adrenergic receptor is a key component of the noradrenergic system. The aim of this study was to evaluate the association between the ADRA2A -1291 C>G polymorphism and the response to MPH treatment in Korean subjects with attention-deficit/hyperactivity disorder (ADHD)... CONCLUSIONS: Our findings provide evidence of an association between the ADRA2A -1291 C>G genotype and response to MPH treatment in Korean subjects with ADHD. Nonetheless, the methodological limitation of not being a randomized placebo-controlled trial and primarily basing results on parent report to clinicians suggest that these results should be viewed as more preliminary.

Efficacy of methylphenidate in the rehabilitation of attention following traumatic brain injury: A randomized, crossover, double-blind, placebo controlled inpatient trial. [2008.12.05]
OBJECTIVES: Most previous studies evaluating use of methylphenidate [generic for Concerta] following traumatic brain injury (TBI) have been conducted many years post-injury. This study evaluated the efficacy of methylphenidate in facilitating cognitive function in the inpatient rehabilitation phase... CONCLUSIONS: Methylphenidate enhances information processing speed in the inpatient rehabilitation phase following TBI. This trial is registered with the Australian New Zealand Clinical Trials Registry (12607000503426).

A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers. [2008.09]
OBJECTIVES: Primary objective was to investigate bioequivalence of Ritalin LA(R); 40 mg compared to Medikinet retard 40 mg in healthy male volunteers under fasted and fed conditions. Secondary objectives included assessment of tolerability and determination of further pharmacokinetic parameters. The difference between the kinetic profiles of Ritalin LA(R) and Medikinet retard with respect to breakfast intake was additionally explored... CONCLUSIONS: Both methylphenidate [generic for Concerta] formulations were safe and well tolerated. Ritalin LA and Medikinet retard were bioequivalent in fasted state but not in fed state. Only Ritalin LA had a biphasic kinetic profile under both fasted and fed conditions. This difference in the kinetic profiles might be of clinical relevance and might offer a potential advantage of Ritalin LA.

Methylphenidate in children with oppositional defiant disorder and both comorbid chronic multiple tic disorder and ADHD. [2008.09]
Our primary objective was to determine if immediate-release methylphenidate [generic for Concerta] is an effective treatment for oppositional defiant disorder diagnosed from mother's report in children with both chronic multiple tic disorder and attention-deficit hyperactivity disorder (ADHD). Children (n = 31) aged 6 to 12 years received placebo and 3 doses of methylphenidate twice daily for 2 weeks each under double-blind conditions and were assessed with ratings scales and laboratory measures...

Pharmacokinetics of methylphenidate transdermal system (MTS): results from a laboratory classroom study. [2008.08]
CONCLUSIONS: Plasma concentrations of the much less active l-MPH were consistently lower than those of d-MPH. The clinical relevance of the MTS pharmacokinetic profile is discussed.

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Clinical Trials Related to Concerta (Methylphenidate)

A Double-Blind Randomized, Placebo-Controlled, Crossover Study of Single Doses of OROS Methylphenidate Hydrochloride (CONCERTA) and Long-Acting Methylphenidate Hydrochloride (RITALIN LA) in Healthy Adults [Completed]
This is a double-blind, placebo-controlled study, three-period crossover study to examine the likeability of a single dose of OROS MPH (CONCERTAÃ’ 90mg) and a single dose of Long-acting MPH (RITALIN LAÃ’ 90mg). Hypotheses are as follows:

Hypothesis 1: OROS-MPH (CONCERTAÃ’) will be later than SODOS-MPH (RITALIN LAÃ’) in its Tmax (time to Cmax).

Hypothesis 2: The subjective feelings of detection and likeability would be greater for SODOS-MPH (RITALIN LAÃ’) than for an equivalent total dose of OROS-MPH (CONCERTAÃ’).

Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate [Completed]
This is a single-blind study looking at the efficacy and satisfaction of Concerta substitution in adult subjects with ADHD receiving immediate release methylphenidate. Subjects will be administered a maximum dose of 1. 3mg/kg/day of either methylphenidate or Concerta. The specific hypotheses of this study are:

Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled in patients switched from MPH IR TID to Concerta.

Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with MPH IR TID.

An Effectiveness and Safety Study Evaluating OROS® Methylphenidate HCl, Ritalin® (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder [Completed]
The purpose of this study is to provide data on the effectiveness of the OROS® Methylphenidate HCl formulation compared to placebo and standard immediate-release Ritalin® with respect to improving attention and behavior, and decreasing hyperactivity in children with Attention Deficit Hyperactivity Disorder (ADHD). Both OROS® Methylphenidate HCl and Ritalin® contain the central nervous system stimulant, methylphenidate HCl. The safety associated with the two methylphenidate formulations will also be compared with placebo.

A Comparative Effectiveness Study Evaluating OROS® Methylphenidate HCl, Ritalin® (Methylphenidate HCl), and Placebo for the Treatment of Attention Deficit Hyperactivity Disorder in Children [Completed]

A Multicenter Study Comparing the Efficacy and Safety of OROS® Methylphenidate HCl, Ritalin® (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder [Completed]
The purpose of this study is to evaluate the efficacy and safety of OROS® Methylphenidate HCl as compared with placebo and standard immediate-release Ritalin® (taken three time per day) for the treatment of Attention Deficit Hyperactivity Disorder in children. Both OROS® Methylphenidate HCl and Ritalin® contain the central nervous system stimulant, methylphenidate HCl.

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CONCERTA PATIENT REVIEWS / RATINGS / COMMENTS

Concerta review by care giver of 13 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		ADD
Dosage & duration:		35 mg taken 1 x day for the period of more than 3 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		My son had a definite and rather dramatic increase in his ability to focus at school, complete his homework and we even saw a difference in his sports performance. He went from grades averaging C's, with some lower, to A & B's for most classes within just a couple of months. Even his teachers were very impressed with the difference, and my son's confidence improved tremendously.
Side effects:		The side effects have been very mild. At some points he seems more argumentative and high strung, but not most of the time. Generally this medication has been well tolerated. We do not administer the medication on the weekends or when he is not at school (during school breaks or during the summer).
Comments:		The treatment with Concerta is simple - he takes one pill a day during the school week. We have semi-annual visits with the Dr. to check on his progress. While starting the medication, we had to adjust the dosage slowly upward. But he had maintained the current dose for more than 1.5 years now with good affects.

Concerta review by care giver of 16 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		ADDH
Dosage & duration:		36mg taken 1 tablet daily for the period of continually, as long as needed for focus
Other conditions:		some mood swings edgyness
Other drugs taken:		none
		Reported Results
Benefits:		patient took this drug to help with concentration and focus problems occurring in a classroom environment with many distractions.
Side effects:		patient preformed with better concentration and focus skills. also helped out in after school homework. less trips from the study table, more time spent studying, and less time having to be reminded to get back to work.
Comments:		patient taking one 36 mg tablet, 7 days a week, in the morning after breakfast. Tablet was a slow release lasting throughout the day.

Concerta review by 35 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		ADHD
Dosage & duration:		27 mg taken once daily for the period of 3 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I was able to concentrate and complete daily tasks. I didn't have to write notes to myself and constantly put them in various places so I would run into during the day.l
Side effects:		I get a bit irritable when the medication wears off for about 30 minutes. I also feel quite tired during this time.
Comments:		My primary care physician prescribe it after telling him my problems I've had my entire life in concentrating/completing tasks. I was also very forgetful but don't have any of these problems except on occasion when I have too many things going on.