Concerta (Methylphenidate Hydrochloride) - Summary

CONCERTA SUMMARY

CONCERTA^® (methylphenidate HCl)
Extended-release Tablets CII

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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NEWS HIGHLIGHTS

Published Studies Related to Concerta (Methylphenidate)

Stimulant treatment reduces lapses in attention among children with ADHD: the effects of methylphenidate on intra-individual response time distributions. [2009.08]
Recent research has suggested that intra-individual variability in reaction time (RT) distributions of children with ADHD is characterized by a particularly large rightward skew that may reflect lapses in attention. The purpose of the study was to provide the first randomized, placebo-controlled test of the effects of the stimulant methylphenidate (MPH) on this tail and other RT distribution characteristics...

Side effects of methylphenidate in childhood cancer survivors: a randomized placebo-controlled trial. [2009.07]
OBJECTIVES: To investigate the frequency and severity of side effects of methylphenidate among childhood survivors of acute lymphoblastic leukemia and brain tumors and identify predictors of higher adverse effect levels... CONCLUSIONS: Methylphenidate is generally well tolerated by childhood cancer survivors. There is a subgroup at increased risk for side effects that may need to be closely monitored or prescribed a lower medication dose. The seemingly paradoxical findings of increased "side effects" at baseline must be considered when monitoring side effects and designing clinical trials.

Behavioral response to methylphenidate challenge: influence of early life parental care. [2009.07]
Rat studies have shown that pups subjected to suboptimal rearing conditions exhibited permanently dysregulated dopamine activity and altered behavioral responses to dopamine stimulation. In humans, heightened stress-induced mesoaccumbens dopamine release in adults reporting low maternal care experience has been shown...

Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. [2009.06]
OBJECTIVE: To assess the efficacy and safety of OROS methylphenidate (Concerta; McNeil Pediatrics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, Titusville, NJ) in the management of attention-deficit/hyperactivity disorder (ADHD) in adults... CONCLUSIONS: In a dose escalation ranging from 36 to 108 mg/d, OROS methylphenidate is effective and well tolerated in the management of ADHD in adults.

Safety of methylphenidate following traumatic brain injury: impact on vital signs and side-effects during inpatient rehabilitation. [2009.06]
OBJECTIVE: The aim of the present study was to evaluate the safety of methylphenidate administered during inpatient rehabilitation following traumatic brain injury... CONCLUSION: Methylphenidate given at 0.3 mg/kg body weight appears to be safe in the inpatient rehabilitation phase. This trial is registered with the Australian New Zealand Clinical Trials Registry (12607000503426).

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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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PATIENT REVIEWS / RATINGS / COMMENTS

Concerta review by care giver of 13 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		ADD
Dosage & duration:		27 MG taken daily for the period of 5 YEARS
Other conditions:		N/A
Other drugs taken:		N/A
		Reported Results
Benefits:		As an ADD child unable to process information propertly, the medication helped her get focused and understand better while in school. Her anxiety level was controlled and helped loose some weight. She was able to control better the outburst socially.
Side effects:		some slight headaches and lacking energy, complainingof being tired.
Comments:		Medication was prescribed while in second grade. Socially and academically it helped her quite significantly. In school she was in special classes and the medicationhas helped her get mainstreamed into regular classes. She is able to soialize a bit better along with therapy. Her level of anxiety is better making her behave a little more relaxed and controlling regular outbursts. It also helped her in her weight due to the anxiety control. Definately able to see the difference when not taking the medication. Difficult to be in school without it.

Concerta review by 38 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		ADHD
Dosage & duration:		36MG taken 1 pill daily for the period of 1 year
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Reduced Attention Deficit Hyperactivity Disorder symptoms, including inattention, hyperactivity, and impulsivity. Allowed for greater concentraion on projects and tasks at hand. Often before taking the medication I would just feel that it's impossible to get organized, to stick to the job at hand, or keep an appointment. Daily tasks of getting up and ready for the day's work, getting to work on time, and being productive at work were difficult.
Side effects:		Appetite seems to fluctuate, usually being low during the middle of the day and more normal by suppertime. Adequate amounts of food that is nutritional seem to be especially helpfull. Appetite seems to fluctuate, usually being low during the middle of the day and more normal by suppertime. Adequate amounts of food that is nutritional seem to be especially helpfull.
Comments:		I was told that in prescribing for an adult, special considerations are made. The adult may need less of the medication for his weight. A medication may have a longer "half-life" in an adult. We started with 19mg and worked up to 36mg. That seemed to be the correct dosage.

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.