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).

See all Concerta indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Concerta (Methylphenidate)

In Children With ADHD Methylphenidate 'Normalizes' Activation In Key Brain Areas
Source: ADHD News From Medical News Today [2013.05.14]
The stimulant drug methylphenidate "normalizes" activation of several brain areas in young patients with attention-deficit/hyperactivity disorder (ADHD), according to a review published in the May Harvard Review of Psychiatry. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health...

Elvanse® (Lisdexamfetamine Dimesylate) Receives UK Marketing Authorisation - New Option For The Treatment Of ADHD In Children And Adolescents
Source: ADHD News From Medical News Today [2013.02.13]
Shire plc (LSE: SHP, NASDAQ: SHPG) have announced that its single-daily dose long-acting prodrug stimulant, Elvanse, has been authorised by the MHRA for the treatment of ADHD in children aged 6 years and over when response to previous methylphenidate treatment is considered clinically inadequate.2 Elvanse is the first stimulant prodrug to be launched in Europe for the treatment of ADHD...

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Published Studies Related to Concerta (Methylphenidate)

Ameliorating attention problems in children with sickle cell disease: a pilot study of methylphenidate. [2012]
disease (SCD) with cerebrovascular complications who evidence attention problems... CONCLUSIONS: Stimulant medication positively impacted select measures of memory

Methylphenidate treatment of adult male prison inmates with attention-deficit hyperactivity disorder: randomised double-blind placebo-controlled trial with open-label extension. [2012]
CONCLUSIONS: Osmotic-release oral system methylphenidate is an effective

Is response to OROS-methylphenidate treatment moderated by treatment with antidepressants or psychiatric comorbidity? A secondary analysis from a large randomized double blind study of adults with ADHD. [2012]
disorders... CONCLUSIONS: We found few moderating effects in this large

Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis. [2011.11.04]
ABSTRACT: BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral psychiatric disorder that afflicts children, with a reported prevalence of 2.4% to 19.8% worldwide. Stimulants (methylphenidate [MPH] and amphetamine) are considered first-line ADHD pharmacotherapy. MPH is a catecholamine reuptake inhibitor, whereas amphetamines have additional presynaptic activity. Although MPH and amphetamine can effectively manage ADHD symptoms in most pediatric patients, many still fail to respond optimally to either. After administration, the prodrug stimulant lisdexamfetamine dimesylate (LDX) is converted to l-lysine and therapeutically active d-amphetamine in the blood. The objective of this study was to evaluate the clinical efficacy of LDX in children with ADHD who remained symptomatic (ie, nonremitters; ADHD Rating Scale IV [ADHD-RS-IV] total score > 18) on MPH therapy prior to enrollment in a 4-week placebo-controlled LDX trial, compared with the overall population... CONCLUSION: In this analysis, children with significant clinical ADHD symptoms despite MPH treatment improved during treatment with LDX and experienced similar improvements in their symptoms as the overall study population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00556296.

Comparison of the Efficacy of Two Different Modified Release Methylphenidate Preparations for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in a Natural Setting: Comparison of the Efficacy of Medikinet((R)) Retard and Concerta((R))-a Randomized, Controlled, Double-Blind Multicenter Clinical Crossover Trial. [2011.10]
Abstract Objective: The comparison of the efficacy of Medikinet((R)) retard and Concerta((R)) trial was a multisite, randomized, double-blind, crossover trial that aimed at comparing the effects of two different modified release methylphenidate preparations (Medikinet retard: 50% immediate release (IR); Concerta: 22% IR) in a natural setting across the day in 113 randomized children and adolescents with attention-deficit/hyperactivity disorder (age range 6-16 years)...

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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 (CONCERTAÒ 90mg) and a single dose of Long-acting MPH (RITALIN LAÒ 90mg). Hypotheses are as follows:

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

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

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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Reports of Suspected Concerta (Methylphenidate) Side Effects

Drug Ineffective (34),  Suicidal Ideation (31),  Overdose (27),  Abnormal Behaviour (26),  Decreased Appetite (25),  Aggression (23),  Psychotic Disorder (21),  Drug Dose Omission (19),  Dizziness (17),  Growth Retardation (17), more >>

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 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.

Concerta review by 39 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		ADHD
Dosage & duration:		18 mg taken 1 a day for the period of 2 days
Other conditions:		Depression
Other drugs taken:		Lexapro, Lamactol , Clonzapam
		Reported Results
Benefits:		None!
Side effects:		Felt like I was speeding out of my mind. I couldn't function, forgot to go to work on time, rectol bleeding, felt like I couldn't breathe, still rectol bleeding after not taking it for 2 days. Have slept alot since not taking it. This had horrible side effects for me from the start. I read the reviews and see I am a older person taking this drug, but I Don't see how anyone could normally function on this drug. I didn't know if I was coming or going and it also made me feel akward when driving. Dangerous drug!
Comments:		>>