Ritalin (Methylphenidate Hydrochloride) - Summary

RITALIN SUMMARY

Ritalin®

Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral administration.

Attention Deficit Disorders, Narcolepsy

Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.

      Ritalin is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.

      Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. 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 one or more of these characteristics.

      Drug treatment is not 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 primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. 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.

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NEWS HIGHLIGHTS

Media Articles Related to Ritalin (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 Ritalin (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 Ritalin (Methylphenidate)

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

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 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).

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.

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.

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Reports of Suspected Ritalin (Methylphenidate) Side Effects

Drug Ineffective (30),  Depression (21),  Suicidal Ideation (20),  Fatigue (20),  Aggression (20),  Attention Deficit/hyperactivity Disorder (20),  Agitation (19),  Anxiety (19),  Disturbance in Attention (19),  Tremor (17), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Ritalin review by 59 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		fibromyalgia
Dosage & duration:		10 mg taken 3 times a day for the period of 10+ years
Other conditions:		migraine, ibs, dry eye syndrome
Other drugs taken:		synthroid, norvasc
		Reported Results
Benefits:		was placed on ritalin due to extreme fatigue assosicated with fibromyalgia. medication highly effective in overcoming lack of energy and the tiredness that would never seem to go away. the fatigue was worse than the physical pain associated with fibromyalgia.
Side effects:		well tolerated--none
Comments:		i take 15 mgs in am and noon and 10 mg late afternoon. this medication has given me a life back and am forever grateful to be on it. this medication sometimes gets a bad rap and does not appear to be used widely for the treatment of fibromyalgia, but for me it is a true, true positive medication with no side effects.

Ritalin review by 28 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		ADD
Dosage & duration:		20mg taken twice a day for the period of 2 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		While i take this drug, i feel very well, happy, I can concentrate in my activities. It helps me to make decisions, I can complete activities, i talk a lot, i stay in a good mood, but just while is during the effects.
Side effects:		My heart beats faster and i feel its not in a constant rhythm. My mouth is dry and I feel extremely anxious, and because of this, very clumsy.
Comments:		My diagnostic of ADD was not really accurate. A did just some practical test but no brain exam. The doctor prescribe ritalin as a test, but because of the side effects I had to stop. I did psychotherapy during the treatment. The ritalin helped me but,of course, didn't stop my problems. I feel really better now, but i didn't find yet a drug to help instead of ritalin.

Ritalin review by 48 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		depression
Dosage & duration:		20 mg/day taken daily for the period of began six months ago
Other conditions:		cancer, high cholesterol
Other drugs taken:		Tamoxifen, Cymbalta, Zyprexa, Lipitor, Valtrex, Cilicaine VX
		Reported Results
Benefits:		When I first began taking the Ritalin, I noticed a dramatic effect on my mood. I felt wonderful! I was energetic and positive and I felt that I could handle anything that came my way. I don't want to sound as though I felt euphoric or manic - I just felt really GOOD about life. However, after only a few days, that sense of confident well-being drained away.
Side effects:		Initially, the medication kept me awake all night but that only happened for a night or two. I take them on an empty stomach in the morning and sometimes my hands shake very slightly for a while but it's not enough to cause any problems.
Comments:		My psychiatrist put me on it to 'give a boost' to my other antidepressant. He says I am taking a miniscule amount, and that I could increase the dosage if I wished but I have been reluctant to do so. Perhaps I should - I may not be taking enough to be effective but I am on three different antidepressants and I feel uneasy about sharply increasing the Ritalin dose. In short, initially, I felt GREAT but now I feel just the same as ever - struggling with the thoughts that cause lack of energy & enjoyment in many spheres of life.