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1.
J Child Psychol Psychiatry ; 58(6): 663-678, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28295312

RESUMO

BACKGROUND: The Multimodal Treatment Study (MTA) began as a 14-month randomized clinical trial of behavioral and pharmacological treatments of 579 children (7-10 years of age) diagnosed with attention-deficit/hyperactivity disorder (ADHD)-combined type. It transitioned into an observational long-term follow-up of 515 cases consented for continuation and 289 classmates (258 without ADHD) added as a local normative comparison group (LNCG), with assessments 2-16 years after baseline. METHODS: Primary (symptom severity) and secondary (adult height) outcomes in adulthood were specified. Treatment was monitored to age 18, and naturalistic subgroups were formed based on three patterns of long-term use of stimulant medication (Consistent, Inconsistent, and Negligible). For the follow-up, hypothesis-generating analyses were performed on outcomes in early adulthood (at 25 years of age). Planned comparisons were used to estimate ADHD-LNCG differences reflecting persistence of symptoms and naturalistic subgroup differences reflecting benefit (symptom reduction) and cost (height suppression) associated with extended use of medication. RESULTS: For ratings of symptom severity, the ADHD-LNCG comparison was statistically significant for the parent/self-report average (0.51 ± 0.04, p < .0001, d = 1.11), documenting symptom persistence, and for the parent/self-report difference (0.21 ± 0.04, p < .0001, d = .60), documenting source discrepancy, but the comparisons of naturalistic subgroups reflecting medication effects were not significant. For adult height, the ADHD group was 1.29 ± 0.55 cm shorter than the LNCG (p < .01, d = .21), and the comparisons of the naturalistic subgroups were significant: the treated group with the Consistent or Inconsistent pattern was 2.55 ± 0.73 cm shorter than the subgroup with the Negligible pattern (p < .0005, d = .42), and within the treated group, the subgroup with the Consistent pattern was 2.36 ± 1.13 cm shorter than the subgroup with the Inconsistent pattern (p < .04, d = .38). CONCLUSIONS: In the MTA follow-up into adulthood, the ADHD group showed symptom persistence compared to local norms from the LNCG. Within naturalistic subgroups of ADHD cases, extended use of medication was associated with suppression of adult height but not with reduction of symptom severity.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/fisiopatologia , Transtorno do Deficit de Atenção com Hiperatividade/terapia , Estatura/fisiologia , Avaliação de Resultados em Cuidados de Saúde , Índice de Gravidade de Doença , Adolescente , Adulto , Assistência ao Convalescente , Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Criança , Terapia Combinada , Feminino , Seguimentos , Humanos , Masculino , Adulto Jovem
2.
Pediatr Int ; 54(6): 838-43, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-22882233

RESUMO

OBJECTIVE: The presence of attention-deficit-hyperactivity disorder (ADHD) symptoms in children with congenital heart disease (CHD) was investigated. METHODS: Swanson, Nolan and Pelham teacher and parent rating scales, version 4 (SNAP-IV), commonly used for assessing symptoms of ADHD, were completed by parents and counselors of children who attended a CHD summer camp. Mean scores (n = 51) were compared with two comparison groups without CHD: patients with ADHD (n = 75) and patients without ADHD (n = 41). Parent scores were also compared to previously published parent normative data. RESULTS: Patients with CHD were reported to have elevated SNAP-IV scores by parents and counselors (11.8%). Parent ratings of inattention were significantly greater in CHD subjects when compared to the comparison group without ADHD (P < 0.001), and similar to the ADHD-positive comparison group. Regarding parent ratings of hyperactivity and impulsivity, the CHD group was significantly lower than the ADHD-positive controls (P = 0.024) but greater than the ADHD-negative controls (P < 0.001). CONCLUSION: ADHD symptoms are more prevalent in children with CHD. Parent ratings of inattention and hyperactivity symptoms in CHD patients are similar to ratings in children diagnosed with ADHD. There is a trend towards a greater prevalence of inattention symptoms in patients with cyanosis or single ventricle physiology.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/epidemiologia , Cardiopatias Congênitas/complicações , Adolescente , Transtorno do Deficit de Atenção com Hiperatividade/complicações , California/epidemiologia , Criança , Feminino , Seguimentos , Cardiopatias Congênitas/epidemiologia , Humanos , Masculino , Prevalência , Estudos Retrospectivos , Inquéritos e Questionários
3.
NPJ Digit Med ; 5(1): 57, 2022 May 05.
Artigo em Inglês | MEDLINE | ID: mdl-35513550

RESUMO

Autism spectrum disorder (ASD) can be reliably diagnosed at 18 months, yet significant diagnostic delays persist in the United States. This double-blinded, multi-site, prospective, active comparator cohort study tested the accuracy of an artificial intelligence-based Software as a Medical Device designed to aid primary care healthcare providers (HCPs) in diagnosing ASD. The Device combines behavioral features from three distinct inputs (a caregiver questionnaire, analysis of two short home videos, and an HCP questionnaire) in a gradient boosted decision tree machine learning algorithm to produce either an ASD positive, ASD negative, or indeterminate output. This study compared Device outputs to diagnostic agreement by two or more independent specialists in a cohort of 18-72-month-olds with developmental delay concerns (425 study completers, 36% female, 29% ASD prevalence). Device output PPV for all study completers was 80.8% (95% confidence intervals (CI), 70.3%-88.8%) and NPV was 98.3% (90.6%-100%). For the 31.8% of participants who received a determinate output (ASD positive or negative) Device sensitivity was 98.4% (91.6%-100%) and specificity was 78.9% (67.6%-87.7%). The Device's indeterminate output acts as a risk control measure when inputs are insufficiently granular to make a determinate recommendation with confidence. If this risk control measure were removed, the sensitivity for all study completers would fall to 51.6% (63/122) (95% CI 42.4%, 60.8%), and specificity would fall to 18.5% (56/303) (95% CI 14.3%, 23.3%). Among participants for whom the Device abstained from providing a result, specialists identified that 91% had one or more complex neurodevelopmental disorders. No significant differences in Device performance were found across participants' sex, race/ethnicity, income, or education level. For nearly a third of this primary care sample, the Device enabled timely diagnostic evaluation with a high degree of accuracy. The Device shows promise to significantly increase the number of children able to be diagnosed with ASD in a primary care setting, potentially facilitating earlier intervention and more efficient use of specialist resources.

4.
CNS Spectr ; 16(4): 85-94, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24725370

RESUMO

UNLABELLED: IntroductionAn in-office linguistic study was conducted to help improve understanding of how to better evaluate and treat attention-deficit/hyperactivity disorder (ADHD). METHODS: Naturally occurring interactions were recorded among 7 psychiatrists and 23 patients and 8 pediatricians along with 22 patients and their parents. Participants were interviewed separately post-visit. Transcripts of interactions and interviews were analyzed using sociolinguistic techniques. RESULTS: Visits were variable in length and lacked concrete treatment plans. In the pediatric setting, children were typically excluded from dialogues, accounting for only 8% of words spoken. School was the primary metric used to evaluate symptoms. Pediatricians allayed parents' concerns about stimulant therapy by promising to prescribe the lowest possible dose, rather than discussing titrating to an optimal dose. Adults were evaluated idiosyncratically without the use of scales or tools. Stimulants were positioned as short-term "trials" without strong physician recommendations.DiscussionConversations about stimulant therapy lacked goal- and expectation-setting. Also missing from conversations was a definitive treatment plan based on the core symptoms of ADHD. Incorporating open-ended questions and tools or rating scales may result in a more effective and efficient in-office dialogue. CONCLUSION: Further research is warranted to assess the efficacy of communication strategies to enhance in-office discussions of ADHD and stimulant therapy.

5.
Perm J ; 252021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33970080

RESUMO

INTRODUCTION: Adolescent depression screening is recommended starting at age 12 years, but younger children experience depression as well. Our objective was to determine whether screening for depression at age 11 years yields similar results to screening at age 12 years. METHODS: We conducted a retrospective chart review of 1000 11- and 12-year-olds in multiple pediatric offices of a large-group practice associated with a health maintenance organization in Southern California. All offices used a multistage depression screening process during well-child visits using the Patient Health Questionnaire for Adolescents, the global depression inquiry within a parent questionnaire, a chart-based review of mental health history, and brief patient/parent interview informed by the first 3 elements. RESULTS: The 11- and 12-year-old cohorts had similar completion rates for the Patient Health Questionnaire for Adolescents (99.2% vs 97.8%, P = 0.06), with similar mean total Patient Health Questionnaire for Adolescents scores (2.12 vs 2.22, P = 0.48). There was no significant difference for positive screenings determined by the pediatrician (12.0% vs 16.0%, P = 0.07), but parents of 12-year-olds were more likely have concerns for their child's mood (6.8% vs 10.5%, P = 0.04). There were similar percentages of referrals (6.2% vs 8.8%, P = 0.12), beneficial conversations related to depression and anxiety, (4.5% vs 4.8%, P = 0.85), and new mental health diagnoses (2.0% vs 2.3%, P = 0.79). DISCUSSION: The process, results, and outcomes of screenings are similar for 11- and 12-year-olds, with a tendency toward more positive findings in 12-year-olds. CONCLUSION: Multistage depression screening in 11-year-olds can be applied successfully in clinical practice, with most cases identifying youths without a prior mental health diagnosis.


Assuntos
Ansiedade , Depressão , Adolescente , Criança , Depressão/diagnóstico , Depressão/epidemiologia , Humanos , Programas de Rastreamento , Saúde Mental , Estudos Retrospectivos , Inquéritos e Questionários
6.
Pediatrics ; 144(2)2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31331984

RESUMO

School readiness includes the readiness of the individual child, the school's readiness for children, and the ability of the family and community to support optimal early child development. It is the responsibility of schools to meet the needs of all children at all levels of readiness. Children's readiness for kindergarten should become an outcome measure for a coordinated system of community-based programs and supports for the healthy development of young children. Our rapidly expanding insights into early brain and child development have revealed that modifiable factors in a child's early experience can greatly affect that child's health and learning trajectories. Many children in the United States enter kindergarten with limitations in their social, emotional, cognitive, and physical development that might have been significantly diminished or eliminated through early identification and attention to child and family needs. A strong correlation between social-emotional development and school and life success, combined with alarming rates of preschool expulsion, point toward the urgency of leveraging opportunities to support social-emotional development and address behavioral concerns early. Pediatric primary care providers have access to the youngest children and their families. Pediatricians can promote and use community supports, such as home visiting programs, quality early care and education programs, family support programs and resources, early intervention services, children's museums, and libraries, which are important for addressing school readiness and are too often underused by populations who can benefit most from them. When these are not available, pediatricians can support the development of such resources. The American Academy of Pediatrics affords pediatricians many opportunities to improve the physical, social-emotional, and educational health of young children, in conjunction with other advocacy groups. This technical report provides an updated version of the previous iteration from the American Academy of Pediatrics published in 2008.


Assuntos
Experiências Adversas da Infância/métodos , Desenvolvimento Infantil/fisiologia , Saúde da Criança , Intervenção Educacional Precoce/métodos , Instituições Acadêmicas , Experiências Adversas da Infância/tendências , Criança , Saúde da Criança/tendências , Pré-Escolar , Intervenção Educacional Precoce/tendências , Humanos , Instituições Acadêmicas/tendências
8.
J Atten Disord ; 12(1): 15-43, 2008 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-18573924

RESUMO

OBJECTIVE: To review and provide details about the primary and secondary findings from the Multimodal Treatment study of ADHD (MTA) published during the past decade as three sets of articles. METHOD: In the second of a two part article, we provide additional background and detail required by the complexity of the MTA to address confusion and controversy about the findings outlined in part I (the Executive Summary). RESULTS: We present details about the gold standard used to produce scientific evidence, the randomized clinical trial (RCT), which we applied to evaluate the long-term effects of two well-established unimodal treatments, Medication Management (MedMGT) and behavior therapy (Beh), the multimodal combination (Comb), and treatment "as usual" in the community (CC). For each of the first three assessment points defined by RCT methods and included in intent-to-treat analyses, we discuss our definition of evidence from the MTA, interpretation of the serial presentations of findings at each assessment point with a different definition of long-term varying from weeks to years, and qualification of the interim conclusions about long-term effects of treatments for ADHD based on many exploratory analyses described in additional published articles. CONCLUSIONS: Using a question and answer format, we discuss the possible clinical relevance of the MTA and present some practical suggestions based on current knowledge and uncertainties facing families, clinicians, and investigators regarding the long-term use of stimulant medication and behavioral therapy in the treatment of children with ADHD.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/terapia , Estimulantes do Sistema Nervoso Central/uso terapêutico , Psicoterapia/métodos , Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Criança , Terapia Combinada , Humanos , Fatores de Tempo , Resultado do Tratamento
9.
J Atten Disord ; 12(1): 4-14, 2008 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-18573923

RESUMO

OBJECTIVE: To review the primary and secondary findings from the Multimodal Treatment study of ADHD (MTA) published over the past decade as three sets of articles. METHOD: In a two-part article-Part I: Executive Summary (without distracting details) and Part II: Supporting Details (with additional background and detail required by the complexity of the MTA)-we address confusion and controversy about the findings. RESULTS: We discuss the basic features of the gold standard used to produce scientific evidence, the randomized clinical trial, for which was used to contrast four treatment conditions: medication management alone (MedMgt), behavior therapy alone (Beh), the combination of these two (Comb), and a community comparison of treatment "as usual" (CC). For each of the three assessment points we review three areas that we believe are important for appreciation of the findings: definition of evidence from the MTA, interpretation of the serial presentations of findings at each assessment point with a different definition of long-term, and qualification of the interim conclusions about long-term effects of treatments for ADHD. CONCLUSION: We discuss the possible clinical relevance of the MTA and present some practical suggestions based on current knowledge and uncertainties facing families, clinicians, and investigators regarding the long-term use of stimulant medication and behavioral therapy in the treatment of children with ADHD.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Transtorno do Deficit de Atenção com Hiperatividade/terapia , Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/uso terapêutico , Criança , Terapia Combinada , Consenso , Humanos , Psicoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
10.
J Psychosoc Nurs Ment Health Serv ; 46(8): 38-48, 2008 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-18777967

RESUMO

Attention-deficit/hyperactivity disorder (ADHD) is a common mental health condition that affects children, adolescents, and adults. Because it is a chronic condition and typically requires effective treatment for several years or more, information on the benefits and risks of long-term pharmacotherapy for ADHD is vital to clinicians. This article reviews the emerging literature on the safety of long-term stimulant medications in ADHD-the most commonly prescribed medications for this condition. Common side effects, including cardiovascular effects, growth effects, and tics, are discussed, as well as treatment of children younger than age 6 and evidence of carcinogenic and reproductive effects.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/efeitos adversos , Assistência de Longa Duração/organização & administração , Gestão da Segurança/organização & administração , Adolescente , Adulto , Fatores Etários , Doenças Cardiovasculares/induzido quimicamente , Estimulantes do Sistema Nervoso Central/uso terapêutico , Criança , Doença Crônica , Monitoramento de Medicamentos/enfermagem , Transtornos do Crescimento/induzido quimicamente , Humanos , Infertilidade/induzido quimicamente , Neoplasias/induzido quimicamente , Avaliação em Enfermagem , Seleção de Pacientes , Enfermagem Psiquiátrica , Medição de Risco , Fatores de Risco , Tiques/induzido quimicamente , Resultado do Tratamento
11.
J Child Adolesc Psychopharmacol ; 17(2): 153-64, 2007 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-17489710

RESUMO

OBJECTIVE: The aim of this study was to compare the pharmacokinetics of immediate-release methylphenidate (MPH) in preschool and school-aged children with attention-deficit/hyperactivity disorder (ADHD). METHODS: Preschool children 4-5 years (n = 14) and school-aged children 6-8 years (n = 9) with diagnoses of ADHD were titrated to an effective dose of MPH based on parent, teacher, and clinician ratings in a protocol specified by the Preschoolers with ADHD Treatment Study (PATS) and then attended a laboratory school where the single morning dose of immediate release MPH was administered. Blood samples for measurement of MPH concentrations were obtained predose, and at 1, 2, 4, and 6 hours postdose. A nonlinear model was used to derive three pharmacokinetic (PK) values for analysis: Peak plasma concentration (C(max)), half-life (t(1/2)), and clearance (CL). RESULTS: The two groups did not differ in the mean mg dose of MPH (p = 0.33), or in the weight-adjusted mg/kg dose (p = 0.20). Dose-normalized C(max) was significantly higher (p = 0.003), and clearance was significantly slower (p = 0.0002) in preschool than in school-aged children. CONCLUSIONS: In this sample, age significantly affected absorption and metabolism of MPH, so that preschool children had greater exposure than school-aged children to the same weight-adjusted dose. These data suggest additional studies should be performed to characterize age-related differences in PK properties of MPH that may inform practitioners about dosing strategies based on the age and size of children being treated.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/sangue , Estimulantes do Sistema Nervoso Central/farmacocinética , Metilfenidato/farmacocinética , Fatores Etários , Área Sob a Curva , Disponibilidade Biológica , Estimulantes do Sistema Nervoso Central/administração & dosagem , Criança , Pré-Escolar , Relação Dose-Resposta a Droga , Feminino , Meia-Vida , Humanos , Masculino , Metilfenidato/administração & dosagem
12.
Arch Pediatr Adolesc Med ; 160(1): 82-90, 2006 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-16389216

RESUMO

BACKGROUND: Despite the persistence of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known about the efficacy and tolerability of stimulant medications in this age group. OBJECTIVE: To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system (OROS) methylphenidate. DESIGN: Adolescents (N = 220) having a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylphenidate that improved symptoms to predefined criteria. Subjects successfully completing the dose titration phase (n = 177) (ie, tolerated and responded to treatment and adhered to the protocol) were randomized to receive 2 weeks' treatment with their individualized dosage of OROS methylphenidate (18, 36, 54, or 72 mg once daily) or placebo. Treatment effectiveness was measured using investigator, parent, and adolescent assessments of ADHD. RESULTS: A significant reduction from baseline in the investigator-rated ADHD Rating Scale, the primary efficacy measure, was found with OROS methylphenidate treatment compared with placebo. Similar findings were noted with parent- and adolescent-report measures. Based on a Clinical Global Impression improvement subscale score of much or very much improved, 52% of subjects in the OROS methylphenidate group improved compared with 31% receiving placebo. Thirty-seven percent of subjects required the maximum dosage of 72 mg/d. The incidence of drug-related adverse events was similar between the 2 study groups. CONCLUSION: In adolescents, once-daily OROS methylphenidate significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/administração & dosagem , Estimulantes do Sistema Nervoso Central/farmacocinética , Metilfenidato/administração & dosagem , Metilfenidato/farmacocinética , Administração Oral , Adolescente , Estimulantes do Sistema Nervoso Central/efeitos adversos , Preparações de Ação Retardada , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Masculino , Metilfenidato/efeitos adversos , Osmose , Resultado do Tratamento
13.
J Am Acad Child Adolesc Psychiatry ; 45(5): 527-537, 2006 May.
Artigo em Inglês | MEDLINE | ID: mdl-16670649

RESUMO

OBJECTIVE: To investigate whether prolonged therapy with a long-acting stimulant affects growth in children with attention-deficit/hyperactivity disorder (ADHD). METHOD: One hundred seventy-eight children ages 6 to 13 years received OROS methylphenidate (OROS MPH, CONCERTA) for at least 21 months. Height and weight were measured monthly during the first year and every 3 months thereafter. RESULTS: At baseline, subjects were approximately the expected height for their age and somewhat heavier than expected. Subjects gained height steadily throughout the study and were on average 0.23 cm less than expected at month 21. Weight did not increase and BMI decreased slightly in the first 4 months. Thereafter, weight Z score and BMI Z score remained relatively constant and children were on average 1.23 kg less than expected at month 21. Previous stimulant therapy tended to be associated with a smaller decrease in Z score during the study compared with no previous stimulant therapy. Drug holidays did not significantly affect growth. CONCLUSIONS: The effects of prolonged OROS MPH therapy on growth were clinically insignificant and limited to slight decreases in weight during the first months of therapy. Drug holidays did not reduce any impact on growth and are thus of questionable utility for limiting potential effects of treatment on growth.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estatura/efeitos dos fármacos , Peso Corporal/efeitos dos fármacos , Estimulantes do Sistema Nervoso Central/efeitos adversos , Metilfenidato/efeitos adversos , Índice de Massa Corporal , Estimulantes do Sistema Nervoso Central/administração & dosagem , Criança , Ensaios Clínicos como Assunto , Preparações de Ação Retardada , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Humanos , Assistência de Longa Duração , Masculino , Metilfenidato/administração & dosagem
14.
J Child Adolesc Psychopharmacol ; 16(3): 351-6, 2006 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16768642

RESUMO

This 8-week, open-label extension of a double-blind study reports on safety data for 171 adolescents with attention-deficit/hyperactivity disorder (ADHD) who received once-daily OROS methylphenidate (MPH) (18-72 mg/day). Headache, anorexia, and insomnia were the most frequently reported treatment-related adverse events. The incidence of adverse events was not related to dose. OROS MPH was safe and well tolerated at doses up to 72 mg/day.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/efeitos adversos , Metilfenidato/efeitos adversos , Adolescente , Anorexia/induzido quimicamente , Estimulantes do Sistema Nervoso Central/administração & dosagem , Estimulantes do Sistema Nervoso Central/uso terapêutico , Esquema de Medicação , Cefaleia/induzido quimicamente , Humanos , Metilfenidato/administração & dosagem , Metilfenidato/uso terapêutico , Distúrbios do Início e da Manutenção do Sono/induzido quimicamente , Redução de Peso
15.
J Am Acad Child Adolesc Psychiatry ; 44(10): 1015-23, 2005 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16175106

RESUMO

OBJECTIVE: Few studies have assessed effectiveness and tolerability of stimulants when used for prolonged periods in children with attention-deficit/hyperactivity disorder (ADHD). This article presents final results from an open-label, multisite study of a once-daily formulation of methylphenidate (MPH), OROS MPH. METHOD: Subjects received OROS MPH (18-54 mg initially, with adjustments based on clinical condition) for up to 24 months. Multiple measures of ADHD symptoms, vital signs, weight, height, and laboratory results were assessed throughout the study period. RESULTS: A total of 407 children enrolled in the open-label study and 229 completed the trial. Effectiveness of OROS MPH therapy was maintained throughout the study as indicated by parent and investigator assessments. There was a 26% increase in mean daily dose over the study period, with the majority of the increase occurring during year 1. In general, treatment was well tolerated, with 31 (7.6%) of subjects discontinuing because of adverse events. Minimal effects on growth in height and weight were observed during the study. No clinically significant effects on vital signs or laboratory test parameters were observed. CONCLUSIONS: : Sustained effectiveness of OROS MPH was maintained for up to 24 months with minimal effects on growth, tics, vital signs, or laboratory test values.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/uso terapêutico , Metilfenidato/uso terapêutico , Adulto , Estimulantes do Sistema Nervoso Central/administração & dosagem , Esquema de Medicação , Feminino , Seguimentos , Humanos , Masculino , Metilfenidato/administração & dosagem , Pessoa de Meia-Idade
16.
Arch Gen Psychiatry ; 60(2): 204-11, 2003 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-12578439

RESUMO

BACKGROUND: The duration of action of the immediate-release formulation of methylphenidate hydrochloride is short (3 to 4 hours), and 3 times daily dosing is thought to maximize effectiveness across a 12-hour day. The initial sustained-release formulations of methylphenidate had reduced efficacy compared with immediate-release methylphenidate and were not well accepted. Tachyphylaxis was hypothesized to account for the reduced effects, and an ascending drug delivery pattern was proposed to overcome this acute tolerance. METHODS: Children with attention-deficit/hyperactivity disorder were evaluated in a laboratory school to characterize onset and duration of the effect of a variety of methylphenidate regimens. In a proof-of-concept study, an experimental ascending profile was established by an initial bolus followed by small increasing doses of immediate-release methylphenidate in capsules administered every 30 minutes for 8 hours. Two proof-of-product studies of a new oral once-a-day formulation to deliver methylphenidate by an osmotic pump process based on OROS (ALZA Corp, Mountain View, Calif) technology (hereafter referred to "OROS-methylphenidate") were conducted: a pharmacokinetic study and a pharmacodynamic study. RESULTS: The experimental ascending profile matched the effect of the standard regimen of methylphenidate, 3 times daily. In the pharmacokinetic study, OROS-methylphenidate treatment produced a rapid rise followed by increasing plasma concentrations that peaked 7 to 9 hours after administration. In the pharmacodynamic study, OROS-methylphenidate treatment matched the 3 times daily dosing of methylphenidate for onset and duration of efficacy. CONCLUSIONS: These studies demonstrate the translation of a basic science finding (acute tolerance to clinical doses of methylphenidate) into clinical application (the selection of a new drug delivery pattern for methylphenidate). This approach produced a new product (OROS-methylphenidate or Concerta), which proved to have the predicted rapid onset (with 1-2 hours) and long duration of efficacy (10-12 hours) after a single administration in the morning.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/administração & dosagem , Metilfenidato/administração & dosagem , Administração Oral , Adolescente , Cápsulas/administração & dosagem , Cápsulas/farmacocinética , Cápsulas/uso terapêutico , Estimulantes do Sistema Nervoso Central/farmacocinética , Estimulantes do Sistema Nervoso Central/uso terapêutico , Criança , Protocolos Clínicos , Estudos de Coortes , Estudos Cross-Over , Preparações de Ação Retardada , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Sistemas de Liberação de Medicamentos , Humanos , Absorção Intestinal , Metilfenidato/farmacocinética , Metilfenidato/uso terapêutico , Placebos , Taquifilaxia/fisiologia , Resultado do Tratamento
17.
J Am Acad Child Adolesc Psychiatry ; 41(11): 1306-14, 2002 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-12410072

RESUMO

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.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/uso terapêutico , Sistemas de Liberação de Medicamentos , Metilfenidato/uso terapêutico , Jogos e Brinquedos , Meio Social , Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Estimulantes do Sistema Nervoso Central/administração & dosagem , Criança , Estudos Cross-Over , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Masculino , Resultado do Tratamento
18.
J Am Acad Child Adolesc Psychiatry ; 42(10): 1234-41, 2003 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-14560174

RESUMO

OBJECTIVE: To determine the pharmacokinetic and pharmacodynamic properties of once-daily versus twice-daily doses of Adderall. METHOD: Following a 1-week wash-out, 12 subjects with attention-deficit/hyperactivity disorder (ADHD) entered a double-blind crossover study comparing two conditions: QD (10 mg of Adderall at 7:30 a.m. and placebo at noon) or BID (10 mg of Adderall at 7:30 a.m. and at noon). At two sites, cohorts of six subjects each were assessed on two different days by a 12-hour laboratory school protocol. Plasma concentrations of d- and l-amphetamine, vital signs, teacher ratings of classroom behavior on the SKAMP, and 10-minute Math Test performance were measured repeatedly over 12 hours. An analysis of variance used center, subject-within-center, condition, and time-after-second-dose as independent variables. RESULTS: The pharmacokinetic profiles revealed similar morning concentrations of d- and l-amphetamine. However, concentrations were twice as high in the afternoon for BID as QD. The two conditions showed similar pharmacodynamic profiles in the morning, although improvement in math performance and behavior was maintained into the afternoon only in the BID condition (p <.05). CONCLUSIONS: This study suggests that twice-daily dosing of Adderall may be an effective strategy for afternoon control of attention and deportment for children with ADHD.


Assuntos
Anfetaminas/farmacologia , Anfetaminas/farmacocinética , Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/farmacologia , Estimulantes do Sistema Nervoso Central/farmacocinética , Administração Oral , Anfetaminas/administração & dosagem , Estimulantes do Sistema Nervoso Central/administração & dosagem , Criança , Feminino , Humanos , Masculino
19.
School Ment Health ; 6(4): 264-278, 2014 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-25506403

RESUMO

This study examines the prevalence and characteristics of services reported by school staff for 543 high school students participating in the 8 year follow-up of the multi-site Multimodal Treatment study of ADHD (MTA). Overall, 51.6% of students with a history of attention-deficit/hyperactivity disorder (ADHD) were receiving services through an Individualized Educational Plan (IEP) or a 504 plan, a rate higher than expected for this age group. Less than 5% of these had 504 plans; 35.5% attended special education classes. Very few services (except tutoring) were provided outside of an IEP or 504 plan. Almost all students with services received some type of academic intervention, whereas only half received any behavioral support or learning strategy. Less than one-fourth of interventions appear to be evidence-based. Students receiving services showed greater academic and behavioral needs than those not receiving services. Services varied based upon type of school, with the greatest number of interventions provided to students attending schools that only serve those with disabilities. Original MTA treatment randomization was unrelated to services, but cumulative stimulant medication and greater severity predicted more service receipt. Results highlight a need for accommodations with greater evidence of efficacy and for increased services for students who develop academic difficulties in high school.

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