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PubMed1995

Prediction of clinical response to methylphenidate in children with attention-deficit hyperactivity disorder.

OBJECTIVE: To examine the pattern of individual responses to to methylphenidate (MPH) in children with attention-deficit hyperactivity disorder and to examine factors that predict drug response. METHOD: Individual drug response was defined on the basis of changes on the Abbreviated Conners Rating Scales completed by parents and teachers. These scales were the main outcome measures in a double-blind, placebo-controlled trial of MPH. Response prediction was examined in stepwise discriminant analyses, in which baseline variables and the response to a single, 10-mg dose of MPH were entered. RESULTS: Predictors of a strong MPH response were a high IQ, considerable inattentiveness, young age, low severity of disorder, and low rates of anxiety. A positive response to a single dose of MPH significantly improved the prediction of less stringently defined levels of MPH response. CONCLUSION: Only strong levels of response could be predicted by baseline characteristics. Severity of disorder based on clinical judgment and improvement after a single dose of MPH are found to be important contributors to response prediction.

Adolescent↗
PubMed1997

Titrating methylphenidate in children with attention-deficit/hyperactivity disorder: is body mass predictive of clinical response?

OBJECTIVE: To evaluate the hypothesis that gross body mass is functionally related to methylphenidate (MPH) response in children with attention deficit disorder/hyperactivity disorder (ADDH). METHOD: Seventy-six children with ADDH received each of five counterbalanced doses of MPH (placebo, 5 mg, 10 mg, 15 mg, 20 mg) in the context of a double-blind, placebo-controlled, within-subject (crossover) experimental design. Dependent measures included direct observations of attention, academic efficiency, and teacher ratings of behavior in the classroom. RESULTS: Dose-response profiles did not differ across children varying incrementally in body mass, nor were systematic variations in dose-response curve parameters observed across discrete groups of children differing in mean body mass. Neither did these groups differ with respect to gains from placebo at each dose. Finally, body mass failed to predict optimal dose or gains achieved at optimal dose and did not distinguish between drug responders and nonresponders. CONCLUSIONS: Collectively, the findings fail to support the practice of titrating MPH on the basis of body weight in children with ADDH.

Analysis of Variance↗
PubMed1997

Effects of methylphenidate on attention and nonverbal learning in children with attention-deficit hyperactivity disorder.

OBJECTIVE: To examine effects of methylphenidate (MPH) doses on attention and learning tasks requiring varying levels of processing in 23 children with attention-deficit hyperactivity disorder. METHOD: Performance on a continuous performance task (CPT) and two difficulty levels of a nonverbal learning task was evaluated on two doses of MPH (0.3 mg/kg and 0.8 mg/kg) and placebo. RESULTS: CPT commission errors were significantly reduced with low-dose MPH compared with placebo while omission errors were not medication-sensitive. Performance on nonverbal learning tasks was significantly improved with MPH. On the easy level of the nonverbal learning task performance improved equally well with either dose. On the hard level, performance was significantly better at the high dose compared with placebo; no between-dose differences emerged across learning trials. However, the high dose was superior to low and placebo doses in memory recall trials. CONCLUSIONS: Impulsivity may be reduced on an attentional task with a low dose of MPH, and a high dose of MPH may optimize retention and recall of complex nonverbal information.

Analysis of Variance↗
PubMed1997

Behavioral, situational, and temporal effects of treatment of ADHD with methylphenidate.

OBJECTIVE: To determine the behavioral, situational, and temporal effects of 4 months of methylphenidate (MPH) treatment for attention-deficit hyperactivity disorder (ADHD). METHOD: Ninety-one children with ADHD were randomly assigned to receive either MPH (titrated to a target dose of 0.7 mg/kg twice a day) or a placebo. Treatment effects were investigated with measures sensitive to various behaviors (core and associated symptoms), situations (home and school), time periods (morning and afternoon, after reaching the target dose, and after 4 months of treatment), and side effects. RESULTS: MPH treatment improved symptoms of ADHD and oppositional behavior at school, both in the morning and afternoon, but not at home. Side effects (increase in physiological and effective symptoms, lack of weight gain) were significantly more frequent with MPH than with placebo treatment. Benefit was evident after titration, but the onset of some side effects was delayed. Side effects were reported by parents but not by teachers. CONCLUSIONS: Positive effects of MPH on behavior are evident in the classroom, but with MPH given twice daily, parents do not report that MPH improves behavior at home. Greater impact on home behavior may require three times daily MPH and combined treatments.

Affect↗
PubMed1999

Predicting methylphenidate response in children with ADHD: theoretical, empirical, and conceptual models.

OBJECTIVE: To evaluate the theoretical merit and empirical validity of models designed to predict response to methylphenidate (MPH) among children with attention-deficit/hyperactivity disorder (ADHD). METHOD: Seventy-six children with ADHD received each of 4 counterbalanced doses of MPH (5, 10, 15, and 20 mg) in the context of a double-blind, placebo-controlled, within-subject (crossover) experimental design. Logical and conceptual foundations of 3 models of MPH response were subjected to critical scrutiny, and patterns of relationship anticipated on the basis of these models were subjected to empirical analysis. RESULTS: The conceptual foundations of all reviewed models were found to be substantially flawed, and none provided an adequate empirical basis for predicting response to MPH among children with ADHD. CONCLUSIONS: The observed pattern of relationships suggests that magnitudes of response to MPH in domains of classroom attention and behavioral disinhibition are correlated and differentially predictive of response on measures of academic performance and teacher-rated behavior.

Attention Deficit Disorder with Hyperactivity↗
PubMed1999

Response to methylphenidate in children with ADHD and comorbid anxiety.

OBJECTIVE: To determine whether comorbid anxiety alters response to methylphenidate (MPH) in children with attention-deficit hyperactivity disorder (ADHD). METHOD: Ninety-one children with ADHD were assessed for anxiety. Children were randomly assigned to receive MPH or placebo, titrated to a dose of 0.7 mg/kg, while side effects were minimized. Measures of side effects and behavioral response were obtained from parents and teachers before treatment, after titration to optimal dose, and after 4 months of treatment. These measures, dose of drug, and rate of adherence to assigned medication assignment were compared for nonanxious (ADHD- ANX) and anxious ADHD children (ADHD+ ANX). RESULTS: Rates of adherence to original medication assignment did not differ between the groups. ADHD+ ANX on both MPH and placebo titrated to a lower dose at the end of titration, although the dose of drug did not differ among the groups after 4 months of treatment. No differential response to MPH between ADHD+ ANX and ADHD- ANX was noted at end-titration or at 4 months on any side effect or behavioral measures. CONCLUSIONS: Comorbid anxiety does not appear to influence development of side effects or behavioral response to MPH when dose is titrated as in standard clinical practice.

Anxiety Disorders↗
PubMed1999

Methylphenidate and behavior modification in children with ADHD and comorbid ODD or CD: main and incremental effects across settings.

OBJECTIVE: Although the combination of methylphenidate (MPH) and behavior modification (BMOD) has been advocated to enhance clinical outcome for children with attention-deficit hyperactivity disorder (ADHD) and comorbid disruptive disorders, few group studies have been conducted. This study evaluates the separate and incremental effects of these modalities on rating scale and observational measures in multiple settings. METHOD: Sixteen of 22 children with ADHD and comorbid disruptive disorder completed a randomized, placebo-controlled study examining the separate and incremental effects of 2 doses of MPH and BMOD during a partial hospitalization program. Of the 6 who did not complete the study, 2 children developed significant side effects. For the 16 who did complete the study, effects were examined on measures of symptom ratings, behavioral frequencies, and stimulant side effects across program activities. RESULTS: Based on alpha-adjusted analyses of variance, there were several main effects of MPH and BMOD on ADHD symptoms, oppositional behavior, and positive social behavior, with certain effects unique to each intervention and setting. One incremental effect each was found for MPH (positive mood/behavior) and BMOD (negative behavior). MPH and BMOD were associated with few side effects. Effect sizes for each intervention showed considerable variability in clinical response. CONCLUSIONS: That MPH and BMOD had certain unique main and incremental effects extends findings supporting their combination and suggests that integrated studies evaluate multiple dimensions of functioning and in novel settings (e.g., home, school). The incorporation of other intervention components in combined treatments may be warranted to enhance clinical efficacy.

Adolescent↗
PubMed1999

Efficacy of methylphenidate among preschool children with developmental disabilities and ADHD.

OBJECTIVE: This was a double-blind, placebo-controlled, crossover design study of the safety and efficacy of methylphenidate (MPH) in 11 preschool children (aged 4.0-5.11 years) with developmental disabilities and attention-deficit hyperactivity disorder (ADHD). METHOD: MPH doses of 0.3 and 0.6 mg/kg per dose and a placebo were given. Drug response was evaluated via teacher-completed behavior checklists and clinic-based observations of activity level, attention, and compliance to adult requests. A side effects checklist was also completed by teachers and parents. RESULTS: Significant improvement on teacher ratings of hyperactivity and inattention as well as clinic-based observations of activity level and compliance were associated with MPH. Eight of 11 preschool children were medication responders (based on a minimum 40% decrease between placebo and one drug condition on either the teacher-rated Conners Hyperactivity Index or the Hyperactive-Distractible subscale of the Preschool Behavior Questionnaire). Five children exhibited significant adverse drug side effects such as severe social withdrawal, increased crying, and irritability, especially at the higher dose (0.6 mg/kg). CONCLUSIONS: Results suggest that preschool children with developmental disabilities and ADHD respond to MPH at rates similar to those of school-age children with mental retardation and ADHD. However, this population appears to be especially susceptible to adverse drug side effects.

Analysis of Variance↗
PubMed1999

Differential effectiveness of methylphenidate and Adderall in school-age youths with attention-deficit/hyperactivity disorder.

OBJECTIVE: To compare the effectiveness of a single dose of Adderall (q.d.) with that of 2 daily doses of methylphenidate (b.i.d.; MPH) as a treatment for attention-deficit/hyperactivity disorder (ADHD) in youths ranging in age from 5 to 17 years. Forty-two youths treated with MPH were compared with 42 youths treated with Adderall. Subjects were matched for age, sex, and DSM-IV diagnostic subtype. METHOD: Youths were assigned to the Adderall or MPH condition by their prescribing physician. All youths were evaluated under 5 conditions, including baseline, placebo, 5 mg, 10 mg, and 15 mg. The best dose was assigned prior to breaking the medication blind and was assigned by the consensus of the psychologist and psychiatrist. Subjective ratings by both teachers and parents were examined for dosage level effects and medication type effects. RESULTS: Best dose was always superior to baseline and placebo conditions. No differences between MPH and Adderall were observed on either teacher or parent ratings of behavior. CONCLUSIONS: Both MPH and Adderall have been shown to be effective treatments for children with ADHD. Both medications appear to improve teachers' and parents' ratings of behavior. Single-dose treatments of Adderall appear to be as effective as 2 daily doses of MPH and therefore increase the possibility of managing treatment without involving the school in medication administration. In addition, youths who have previously been unsuccessfully treated with MPH because of adverse side effects or poor response may be successfully treated with Adderall.

Adolescent↗
PubMed1999

Do typical clinical doses of methylphenidate cause tics in children treated for attention-deficit hyperactivity disorder?

OBJECTIVE: To determine whether typical clinical doses of methylphenidate (MPH) cause tics or exacerbate preexisting mild to moderate tics. METHOD: Ninety-one children with attention-deficit hyperactivity disorder, with and without comorbid tics (excluding severe tics and Tourette's syndrome), were randomly assigned to receive MPH or a placebo in a 1-year prospective study. The target dose was titrated to balance behavior change and side effects. Parents and teachers were the observers. RESULTS: Crossover from the placebo to MPH was common because of poor behavioral response. One MPH-treated subject dropped out; the final MPH group had 72 subjects; the placebo group, 18. The average dose of MPH was 0.5 mg/kg twice daily. Clinically significant tics developed in 19.6% of the subjects without preexisting tics receiving MPH and in 16.7% of those receiving the placebo (Fisher exact test, p = .59, not significant; relative risk = 1.17, confidence interval = 0.31-4.40). Deterioration of tics was observed in 33% of subjects with preexisting tics receiving MPH and in 33% of those receiving the placebo (Fisher exact test, p = .70, not significant; relative risk = 1.0, confidence interval = 0.40-1.85). CONCLUSIONS: Doses of MPH based on the typical clinical titration procedure did not produce significantly more tics than the placebo in children with or without preexisting (mild to moderate) tics.

Attention Deficit Disorder with Hyperactivity↗
PubMed2000

Predictors of adult height and weight in boys treated with methylphenidate for childhood behavior problems.

OBJECTIVE: To examine associations between childhood treatment with methylphenidate (MPH) and adult height and weight. METHOD: Subjects were 97 boys, aged 4 to 12 years, with behavior problems who were (1) referred to a child psychiatry outpatient clinic, (2) treated clinically with MPH for an average of 36 months, and (3) reevaluated between ages 21 and 23 years. Hierarchical analyses predicted adult height and weight from sets of non-medication and medication-related variables. RESULTS: Medicated subjects' age, height, and parental socioeconomic status (SES) at referral predicted 44.8% of variation in adult height. Medicated subjects' birth weight, age, height and weight at referral, and parental SES predicted 61.8% of variation in adult weight. With these non-medication variables held constant, initial nausea and vomiting side effects predicted 4.4% incremental variation in adult height, and MPH maintenance dose predicted 3.2% incremental variation in adult weight. CONCLUSIONS: Medicated individuals who had attained their final stature did not differ in average height or weight from family, community, or unmedicated controls. Most aspects of medication were not associated with adult height or weight. In some individuals, nausea and vomiting side effects and treatment with higher doses of MPH were associated with adult growth decrements.

Adult↗
PubMed2001

Impairment and deportment responses to different methylphenidate doses in children with ADHD: the MTA titration trial.

OBJECTIVE: Results of the NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder (MTA) were analyzed to determine whether a double-blind, placebo-controlled methylphenidate (MPH) titration trial identified the best MPH dose for each child with attention-deficit/hyperactivity disorder (ADHD). METHOD: Children with ADHD assigned to MTA medication treatment groups (n = 289) underwent a controlled 28-day titration protocol that administered different MPH doses (placebo, low, middle, and high) on successive days. RESULTS: A repeated-measures analysis of variance revealed main effects for MPH dose with greater effects on teacher ratings of impairment and deportment (F3 = 100.6, n = 223, p = .0001; effect sizes 0.8-1.3) than on parent ratings of similar endpoints (F3 = 55.61, n = 253, p = .00001; effect sizes 0.4-0.6). Dose did not interact with period, dose order, comorbid diagnosis, site, or treatment group. CONCLUSIONS: The MTA titration protocol validated the efficacy of weekend MPH dosing and established a total daily dose limit of 35 mg of MPH for children weighing less than 25 kg. It replicated previously reported MPH response rates (77%), distribution of best doses (10-50 mg/day) across subjects, effect sizes on impairment and deportment, as well as dose-related adverse events.

Analysis of Variance↗
PubMed2001

Methylphenidate dosage for children with ADHD over time under controlled conditions: lessons from the MTA.

OBJECTIVES: To examine the trajectory of methylphenidate (MPH) dosage over time, following a controlled titration, and to ascertain how accurately the titration was able to predict effective long-term treatment in children with attention-deficit/hyperactivity disorder (ADHD). METHOD: Using the 14-month-treatment database of the NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder (MTA), the outcome of the initial placebo-controlled, double-blind, randomized daily switch titration of MPH was compared with the subsequent maintenance pharmacotherapy. Children received monthly monitoring visits and, when needed, medication adjustments. RESULTS: Of the 198 children for whom MPH was the optimal treatment at titration (mean +/- SD dose: 30.5 +/- 14.2 mg/day), 88% were still taking MPH at the end of maintenance (mean dose 34.4 +/- 13.3 mg/day). Titration-determined dose and end-of-maintenance dose were significantly correlated (r = 0.52-0.68). Children receiving combined pharmacotherapy and behavioral treatment ended maintenance on a lower dose (31.1 +/- 11.7 mg/day) than did children receiving pharmacotherapy only (38.1 +/- 14.2 mg/day). Of the 230 children for whom titration identified an optimal treatment, 17% continued both the assigned medication and dosage throughout maintenance. The mean number of pharmacological changes per child was 2.8 +/- 1.8 (SD), and time to first change was 4.7 months +/- 0.3 (SE). CONCLUSIONS: For most children, initial titration found a dose of MPH in the general range of the effective maintenance dose, but did not prevent the need for subsequent maintenance adjustments. For optimal pharmacological treatment of ADHD, both careful initial titration and ongoing medication management are needed.

Attention Deficit Disorder with Hyperactivity↗
PubMed2001

Short-term cardiovascular effects of methylphenidate and adderall.

OBJECTIVE: The primary purpose of this study was to examine the cardiovascular effects of Adderall (ADL) in a clinic-based group of youths with attention-deficit/hyperactivity disorder ranging in age from 4 to 17 years. METHOD: One hundred thirty-seven patients were treated with either methylphenidate (MPH) or ADL. Youths prescribed MPH were given medication twice daily, and youths treated with ADL received medication once daily. Patients were evaluated under five conditions: baseline, placebo, 5 mg/dose, 10 mg/dose, or 15 mg/dose. Resting pulse, diastolic blood pressure, and systolic blood pressure were examined after 1 week at each treatment condition. Changes from baseline on these parameters were examined. RESULTS: The short-term cardiovascular effects of both ADL and MPH were modest. No patients experienced any clinically significant change in these cardiovascular measures during the course of this brief trial. CONCLUSION: Since the short-term cardiovascular effects of ADL appear minimal, specific cardiovascular monitoring during short-term ADL treatment at doses of 15 mg/day or less does not appear to be indicated. In addition, under similar conditions, using similar methods, both medication treatments led to changes in blood pressure and pulse that were clinically insignificant.

Adolescent↗
PubMed2002

Efficacy of a new pattern of delivery of methylphenidate for the treatment of ADHD: effects on activity level in the classroom and on the playground.

OBJECTIVES: To evaluate the pharmacodynamic effects of an experimental (EXP) delivery of methylphenidate (MPH) in children with attention-deficit/hyperactivity disorder and to investigate the situational nature of effects in laboratory classroom and playground settings. METHOD: A "sipping" study methodology was used to deliver a bolus followed by small but increasing MPH doses as the EXP regimen. A randomized, double-blind crossover design was used to compare the EXP regimen to a thrice-daily (TID) regimen and a placebo (PLA) regimen. Measures of efficacy were obtained from a Motionlogger actigraph to quantify activity and from the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale to quantify two domains of behavior (attention and deportment). RESULTS: Compared with PLA, both EXP and TID delivery of MPH produced large, significant reductions in activity and inappropriate behavior in the classroom, but the two MPH regimens did not differ in onset or duration of effects across the day. The MPH effects were situationally dependent and were smaller for the playground than for the classroom settings. CONCLUSIONS: The findings of this "proof of concept" study support the efficacy of a continuous, ascending delivery of MPH. The situational effects of MPH provide support for the theory of selective effects of stimulants, dependent on the demands of the environment.

Attention Deficit Disorder with Hyperactivity↗
PubMed2004

Methylphenidate improves visual-spatial memory in children with attention-deficit/hyperactivity disorder.

OBJECTIVE: To investigate the effect of methylphenidate (MPH) on visual-spatial memory, as measured by subtests of the Cambridge Neuropsychological Testing Automated Battery (CANTAB), in children with attention-deficit/hyperactivity disorder (ADHD). Visual-spatial memory is a core component of working memory that has been shown to be impaired in ADHD, irrespective of comorbid reading and/or language problems. METHOD: A clinic-referred sample of school-age children with a confirmed DSM-IV diagnosis of ADHD (n = 26) completed tests of visual-spatial memory, planning ability, and recognition memory in an acute, randomized, placebo-controlled, crossover trial with three single fixed doses of MPH. MPH effects on right-handed and left-handed motor control were also assessed. RESULTS: MPH significantly improved performance on a self-ordered, updating visual-spatial working memory task and on maintenance of visual-spatial information but had no effects on measures of visual-spatial planning ability or recognition memory. Also, MPH significantly improved left-handed motor control. CONCLUSIONS: Beneficial effects of MPH on visual-spatial processing in ADHD are selective and restricted to visual-spatial memory.

Attention Deficit Disorder with Hyperactivity↗
PubMed2004

Impact of methylphenidate delivery profiles on driving performance of adolescents with attention-deficit/hyperactivity disorder: a pilot study.

OBJECTIVE: Adolescents with attention-deficit/hyperactivity disorder (ADHD) are at high risk for driving accidents. One dose of methylphenidate (MPH) improves simulator driving performances of ADHD-diagnosed adolescents at 1.5 hours post-dose. However, little is known about the effects of different MPH delivery profiles on driving performance throughout the day. METHOD: This randomized, crossover, single-blind study compared osmotic, controlled-release oral system (OROS) MPH (Concerta) given q.d. to immediate-release MPH (Ritalin) given in equal doses t.i.d. on driving performance among six male ADHD-diagnosed adolescent drivers aged 16 to 19 years. Under each treatment condition, participants were maintained on their medication dosage for 7 days, then drove a sophisticated driving simulator at 2 p.m., 5 p.m., 8 p.m., and 11 p.m. The primary outcome measure was each participant's computer-quantified Impaired Driving Score (IDS). RESULTS: IDS worsened in the evenings for participants receiving MPH t.i.d. but remained stable when they received once-daily OROS MPH. Participants performed significantly better when receiving OROS MPH q.d. compared with MPH t.i.d. (F = 9.3, df = 1, p =.004). When MPH was given t.i.d., IDS significantly worsened beginning at 8 p.m. compared to OROS MPH (p =.01). CONCLUSIONS: Participants demonstrated significantly less variability and better driving performance when receiving OROS MPH q.d. compared to MPH t.i.d., particularly in the evenings.

Adolescent↗
PubMed1986

Suspected adverse methylphenidate-imipramine interactions in children.

Two cases are presented which illustrate the dangers inherent in utilizing a polypharmacy approach in treating children with psychotropic medication. In each case, severe adverse effects, including cognitive and mood deterioration, were experienced by the child when treated with a combination of methylphenidate and imipramine. Possible mechanisms at the neurotransmitter level are described as postulated determinants for this pharmacological interaction.

Adolescent↗