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Methylphenidate

Methylphenidate (MPH) is an amphetamine-like prescription stimulant commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults. It is also one of the primary drugs used to treat symptoms of traumatic brain injury and the daytime drowsiness symptoms of narcolepsy and chronic fatigue syndrome. Brand names of drugs that contain methylphenidate include Ritalin®, Concerta® (a timed-release capsule), Metadate®, Methylin® and Rubifen®. more...

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Focalin® is a preparation containing only dextro-methylphenidate, rather than the usual racemic dextro- and laevo-methylphenidate mixture of other formulations.

History

Methylphenidate was patented in 1954 by the Ciba Pharmaceutical Company (a precursor to Novartis) and was initially prescribed as a treatment for depression, chronic fatigue, and narcolepsy, among other ailments. Beginning in the 1960s, it was used to treat children with ADHD, known at the time as hyperactivity or minimal brain dysfunction (MBD). Today methylphenidate is the medication most commonly prescribed to treat ADHD around the world. According to most estimates, more than 75 percent of methylphenidate prescriptions are written for children, with boys being about four times as likely to take methylphenidate as girls. Production and prescription of methylphenidate rose significantly in the 1990s, especially in the United States, as the ADHD diagnosis came to be better understood and more generally accepted within the medical and mental health communities.

Most brand-name Ritalin is produced in the United States, although methylphenidate is also produced in Mexico and Argentina by respective contract pharmaceutical manufacturers and is marketed under the brand name "Ritalin" for Novartis. In the United States, various generic forms of methylphenidate are also produced by several pharmaceutical companies (such as Methylin, etc.), and Ritalin is also sold in the United Kingdom, Germany, and other European countries (although in much lower volumes than the United States). Another medicine is Concerta. This was approved around the date of April 2000.

Effects

Methylphenidate is a central nervous system (CNS) stimulant. It has a "calming" effect on many children who have ADHD, reducing impulsive behavior and the tendency to "act out", and helps them concentrate on schoolwork and other tasks. Adults who have ADHD often find that MPH increases their ability to focus on tasks and organize their lives.

The means by which methylphenidate helps people with ADHD are not well understood. Some researchers have theorized that ADHD is caused by a dopamine imbalance in the brains of those affected. MPH is a dopamine reuptake inhibitor, which means that it increases the level of the dopamine neurotransmitter in the brain by partially blocking the transporters that remove it from the synapses.

In the United States, methylphenidate is classified as a Schedule II controlled substance, the designation used for substances that have a recognized medical value but which have a high potential for abuse. Internationally, methylphenidate is a Schedule II drug under the Convention on Psychotropic Substances. Some people abuse MPH by crushing the tablets and snorting them, the "high" resulting from the higher equivalent dose being absorbed rapidly into the bloodstream. The effect of Ritalin is similar to that of cocaine or amphetamine and such abuse can lead to addiction. When taken orally in prescribed doses, MPH is less addictive and may not produce a "high". After taking the drug or resuming it after going a month or more without it, the effects of dependence will tend to level off after a week, and again, after a month.

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Is methylphenidate useful for treating adolescents with ADHD?
From Journal of Family Practice, 8/1/04 by Timothy F. Mott

* EVIDENCE-BASED ANSWER

Methylphenidate (Ritalin) is effective in the short-term treatment of attention deficit/hyperactivity disorder (ADHD) (strength of recommendation [SOR]: A, multiple randomized control trials).

Though the immediate-release preparation is the best studied of methylphenidate formulations, extended-release methylphenidate (Concerta) has similar benefits, with a dosing regimen that may better suit an adolescent lifestyle (SOR: B, based on extrapolation of 1 randomized controlled trial and expert opinion).

* EVIDENCE SUMMARY

The subjects of most ADHD medication studies have been school-age children. Most children with ADHD will have symptoms persisting into teenage years, and methylphenidate has been increasingly prescribed for them. (1,2) Various systematic reviews and meta-analyses have demonstrated the effectiveness of short-term methylphenidate in the treatment of adolescents with ADHD. (3-5) Most participants in these studies are males aged <13 years. Therefore, any conclusions about the effectiveness of methylphenidate in older adolescents must be inferred.

The most comprehensive systematic review found 8 well-controlled crossover trials with an average sample size of 24.8 (range, 9-48). (6) The average duration of the studies was 6 weeks. The majority of the participants were white males with a mean age of 13 years. Each study showed statistically significant improvement from treatment with methylphenidate. Average effect sizes were calculated for 3 domains: ADHD symptoms (0.94), social behavior (1.06), and academic performance (1.25). Effect sizes were calculated using a modified Cohen's d, which is the difference between the treated and untreated means divided by the standard deviation in the untreated condition. It is difficult to translate these changes in effect size into clinically meaningful outcome measures, although one rule of thumb estimates an effect size of 0.8 is moderate to large.

Of the 3 studies that reported the proportion of subjects with clinically significant improvement, the modal result was about one half showings improvement with methylphenidate. Of trials assessing dosing levels, <50% found significant differences between "low" and "high" doses. However, the researchers did not give their definition of low and high doses. Also, diminishing clinical improvement was noted with higher methylphenidate doses.

A single study on the once-daily stimulant preparation, extended-release methylphenidate, shows statistically significant improvement in adolescent ADHD. (7) In this multicenter, randomized, double-blind, placebo-controlled trial of 177 adolescents, subjects were given placebo (n=87) or extended-release methylphenidate (n=90) at titrated doses from 18 mg/d to 72 mg/d. Following a subsequent 2-week randomization phase, clinical investigators found extended-release methylphenidate significantly superior to placebo (P=.001) on the ADHD scale. Subjects also rated it significantly superior to placebo (P=.001) on the Conners-Wells' Self-Report Scale. Mean dose and average age were not reported. This study has been presented as an abstract and is not yet published.

* RECOMMENDATIONS FROM OTHERS

The American Academy of Child and Adolescent Psychiatry (AACAP) supports the prescribing of methylphenidate in adolescents with ADHD. (8) Given the unique psychosocial, environmental, and scheduling challenges of adolescence, the AACAP mentions extended-release methyl-phenidate as "well-suited for treatment of adolescents."

Timothy F. Mott, MD, Navy Hospital Pensacola Family Practice Residency, Pensacola, Fla; Laura Leach, MLIS, Carolinas Healthcare System, Charlotte AHEC, Charlotte, NC

* CLINICAL COMMENTARY:

Patients with childhood ADHD usually benefit from continuing their medication

Adolescents must face the challenge of becoming more organized and independent to be successful in middle school and high school. Those with childhood ADHD may have a particularly difficult transition, and will usually benefit from continuing to take their stimulants. Some adolescents, who were not previously identified as having ADHD, may declare themselves at this age due to school performance issues. Careful evaluation and treatment of these patients will contribute to their success.

Physicians should use the lowest effective dose of methylphenidate, as the studies seem to indicate that higher dosages do not improve performance in adolescents. Teens often prefer long-acting preparations, which obviate the need to take medication at school. The studies reviewed do not define long-term academic or vocational success, which is a more important outcome than symptom control for adolescents.

Lisa Johnson, MD, Providence St. Peter's Family Practice Residency, Olympia, Wash

REFERENCES

(1.) Safer DJ, Zito JM, Fine EM. Increased methylphenidate usage for attention deficit disorder in the 1990s. Pediatrics 1996; 98:1084-1088.

(2.) Fischer M, Barkley RA, Edelbrock CS, Smallish L. The adolescent outcome of hyperactive children diagnosed by research criteria: II. Academic, attentional, and neuropsychological status. J Consult Clin Psychol 1990; 58:580-588.

(3.) Klassen A, Miller A, Raina P, Lee SK, Olsen L. Attention-deficit hyperactivity disorder in children and youth: a quantitative systematic review of the efficacy of different management strategies. Can J Psychiatry 1999; 44:1007-1016.

(4.) Schachar R, Jadad AR, Gauld M, et al. Attention-deficit hyperactivity disorder: critical appraisal of extended treatment studies. Can J Psychiatry 2002; 47:337-348.

(5.) Schachter HM, Pham B, King J, Langford S, Moher D. How efficacious and safe is short-acting methylphenidate for the treatment of attention-deficit disorder in children and adolescents? A meta-analysis. CMAJ 2001; 165:1475-1488.

(6.) Smith BH, Waschbusch DA, Willoughby MT, Evans S. The efficacy, safety, and practicality of treatments for adolescents with attention deficit/hyperactivity disorder (ADHD). Clin Child Fam Psychol Rev 2000; 3:243-267.

(7.) Greenhill LL. Safety and Efficacy of OROS MPH in Adolescents with ADHD. Program and Abstracts of the American Psychiatric Association, 156th Annual Meeting; Scientific and Clinical Reports. May 17-22, 2003; San Francisco, Calif. Abstract S&CR12-37.

(8.) Greenhill LL, Pliszka S, Dulcan MK, et al. Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults. J Am Acad Child Adolesc Psychiatry 2002; 41 (2 Suppl):26S-49S.

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