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Abstract: Purpose: Young adults with ADHD have been shown to be at increased risk for impairment in driving behaviors. Although stimulant medications have proven efficacy in reducing ADHD symptomatology, there is limited knowledge as to their effects on driving behavior. The focus of this report is on assessing the impact of lisdexamfetamine dimesylate (LDX) on driving behaviors in young adults with ADHD using a validated driving behavior questionnaire. Methods: This assessment was carried out in the context of a randomized, double-blind, 6-week, placebo-controlled, parallel-design study of LDX versus placebo. Subjects were 61 outpatients of both sexes, 18–26 years of age, who met Diagnostic and Statistical Manual of Mental Disorders, fourth edition, criteria for ADHD. Subjects were randomized to receive LDX or placebo for 6 weeks. Driving behavior was assessed at baseline and at the end of treatment using a U.S. version of the Manchester Driving Behavior Questionnaire (DBQ). Results: Highly significant improvements were documented on LDX, over placebo, in driving behaviors assessed through the DBQ in measures of driving errors, driving lapses, and a trend toward fewer driving violations. There were no meaningful associations between these DBQ results and previously documented changes in a laboratory driving simulation paradigm or with improvement in symptoms of ADHD assessed through the ADHD rating scale. Conclusions: LDX treatment was associated with significant improvements in self-reported driving behaviors that were independent of improvement in symptoms of ADHD. These results suggest that LDX may reduce behaviors associated with driving risks in young adults with ADHD. [Copyright &y& Elsevier]

The article focuses on a study which investigated the effects of the methylphenidate transdermal system (MTS) on before-school attention-deficit/hyperactivity disorder (ADHD) symptoms and functioning in children with ADHD. The study included children aged six to 12 years, who were randomized to receive either MTS or placebo between May 2007 and December 2008. It found that MTS is effective in controlling morning ADHD symptoms and improving the activities and functioning in children with ADHD.

An evidence-based systematic review including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing. [ABSTRACT FROM AUTHOR]

An evidence-based systematic review including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology and dosing. [ABSTRACT FROM AUTHOR]

Summary: Objective: To evaluate the scientific evidence on guggul for hyperlipidemia including expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing. Methods: Electronic searches were conducted in nine databases, 20 additional journals (not indexed in common databases), and bibliographies from 50 selected secondary references. No restrictions were placed on language or quality of publications. All literature collected pertained to efficacy in humans, dosing, precautions, adverse effects, use in pregnancy/lactation, interactions, alteration of laboratory assays, and mechanism of action. Standardized inclusion/exclusion criteria were utilized for selection. Results: Before 2003, most scientific evidence suggested that guggulipid elicits significant reductions in serum total cholesterol, low-density lipoprotein (LDL), and triglycerides, as well as elevations in high-density lipoprotein (HDL) [Kotiyal JP, Bisht DB, Singh DS. Double blind cross-over trial of gum guggulu (Commiphora mukul) Fraction A in hypercholesterolemia. J Res Indian Med Yoga Hom 1979;14(2):11–6; Kotiyal JP, Singh DS, Bisht DB. Gum guggulu (Commiphora mukul) fraction ‘A’ in obesity—a double-blind clinical trial. J Res Ayur Siddha 1985;6(1, 3, 4):20–35; Gaur SP, Garg RK, Kar AM, et al. Gugulipid, a new hypolipidaemic agent, in patients of acute ischaemic stroke: effect on clinical outcome, platelet function and serum lipids. Asia Pacif J Pharm 1997;12:65–9; Urizar NL, Liverman AB, Dodds DT, et al. A natural product that lowers cholesterol as an antagonist ligand for the FXR. Science 3 May 2002 [Science Express Reports]; Nityanand S, Srivastava JS, Asthana OP. Clinical trials with gugulipid. A new hypolipidaemic agent. J Assoc Physicians India 1989;37(5):323–8; Kuppurajan K, Rajagopalan SS, Rao TK, et al. Effect of guggulu (Commiphora mukul—Engl.) on serum lipids in obese, hypercholesterolemic and hyperlipemic cases. J Assoc Physicians India 1978;26(5):367–73; Gopal K, Saran RK, Nityanand S, et al. Clinical trial of ethyl acetate extract of gum gugulu (gugulipid) in primary hyperlipidemia. J Assoc Physicians India 1986;34(4):249–51; Agarwal RC, Singh SP, Saran RK, et al. Clinical trial of gugulipid—a new hypolipidemic agent of plant origin in primary hyperlipidemia. Indian J Med Res 1986;84:626–34; Verma SK, Bordia A. Effect of Commiphora mukul (gum guggulu) in patients of hyperlipidemia with special reference to HDL-cholesterol. Indian J Med Res 1988;87:356–60; Singh RB, Niaz MA, Ghosh S. Hypolipidemic and antioxidant effects of Commiphora mukul as an adjunct to dietary therapy in patients with hypercholesterolemia. Cardiovasc Drugs Ther 1994;8(4):659–64; Ghorai M, Mandal SC, Pal M, et al. A comparative study on hypocholesterolaemic effect of allicin, whole germinated seeds of bengal gram and guggulipid of gum gugglu. Phytother Res 2000;14(3):200–02]. However, most published studies were small and methodologically flawed. In August 2003, a well-designed trial reported small significant increases in serum LDL levels associated with the use of guggul compared to placebo [Szapary PO, Wolfe ML, Bloedon LT, et al. Guggulipid for the treatment of hypercholesterolemia: a randomized controlled trial. JAMA 2003;290(6):765–72]. No significant changes in total cholesterol, high-density lipoprotein (HDL), or triglycerides were measured. These results are consistent with two prior published case reports [Das Gupta R. Gugulipid: pro-lipaemic effect. J Assoc Physicians India 1990;38(12):346]. Conclusion: The effects of guggulipid in patients with high cholesterol are not clear, with some studies finding cholesterol-lowering effects, and other research suggesting no benefits. At this time, there is not enough scientific evidence to support the use of guggul for any medical condition. Guggul may cause stomach discomfort or allergic rash as well as other serious side effects and interactions. It should be avoided in pregnant or breast-feeding women and in children. Safety of use beyond 4 months has not been well studied. [Copyright &y& Elsevier]

An evidence-based systematic review including scientific evidence, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing. [ABSTRACT FROM AUTHOR]

The proposed uses, dosing parameters, adverse effects, toxicology, interactions and mechanism of action of kava is systematically reviewed in monograph format. [ABSTRACT FROM AUTHOR]

Background: The main aim of this study was to compare the safety and efficacy of IR MPH administered three times daily to those of once daily OROS-MPH. Methods: Subjects were outpatient adults satisfying full diagnostic criteria for DSM-IV ADHD between 19 and 60 years of age. Data from two independently conducted 6-week placebo controlled, randomized clinical trials of IR-MPH (tid) and of OROS-MPH were pooled to create three study groups: Placebo (N = 116), IR-MPH (tid) (N = 102) and OROS-MPH (N = 67). Results: Eight-five percent (N = 99) of placebo treated subjects, 77% (N = 79) of the IR-MPH (tid) treated subjects, and 82% (N = 55) of the OROS-MPH treated subjects completed the 6-week trial. Total daily doses at endpoint were 80.9 ± 31.9 mg, 74.8 ± 26.2 mg, and 95.4 ± 26.3 mg in the OROS-MPH, IR-MPH (tid), and placebo groups, respectively. At endpoint, 66% (N = 44) of subjects receiving OROS-MPH and 70% (N = 71) of subjects receiving IR-MPH (tid) were considered responders compared with 31% (N = 36) on placebo. Conclusion: Comparison of data from two similarly designed, large, randomized, placebo-controlled, trials, showed that equipotent daily doses of once daily OROS-MPH had similar efficacy to that of TID administered IR MPH. Trial Registration: The trial of OROS-MPH was registered at clinicaltrials.gov, number NCT00181571.

Objective: Although attention-deficit hyperactivity disorder (ADHD) is a well-known risk factor for cigarette smoking, prospective studies aimed at reducing smoking risk in this population are critically needed. Study design: This was a 2-year, prospective, open-label clinical trial of extended-release methylphenidate for smoking prevention in adolescents with ADHD (n = 154). Smoking outcomes were assessed with the Fagerstrom Tolerance Questionnaire. Comparisons were made using data from a historical, naturalistic sample of ADHD (n = 103) and non-ADHD comparators (n = 188) of similar age and sex assessed with the same assessment battery as that used in subjects participating in the clinical trial. Results: The smoking rate at endpoint (mean, 10 months of methylphenidate treatment) was low in the clinical trial subjects and not significantly different from that in the non-ADHD comparators or the ADHD comparators receiving stimulants naturalistically (7.1% vs 8.0% vs 10.9%; P > .20). In contrast, the smoking rate was significantly lower in the clinical trial subjects than in the naturalistic sample of ADHD comparators who were not receiving stimulant treatment (7.1% vs 19.6%; P = .009 [not significant], adjusting for comorbid conduct disorder and alcohol and drug abuse). Conclusion: Although considered preliminary until replicated in future randomized clinical trials, the findings from this single-site, open-label study suggest that stimulant treatment may contribute to a decreased risk for smoking in adolescents with ADHD. If confirmed, this finding would have significant clinical and public health impacts. [ABSTRACT FROM AUTHOR]

Objective: To examine the effects of high doses of extended-release methylphenidate (OROS MPH) on cardiovascular variables in adolescents with attention deficit hyperactivity disorder (ADHD). Study design: ECG indices plus systolic blood pressure (SBP), diastolic BP (DBP) and heart rate (HR) were assessed during an open-label study of OROS MPH in 114 adolescents with ADHD (doses up to 1.5 mg/kg/d). Cardiovascular parameters were assessed at 6 weeks and 6 months. Results: Small but statistically significant changes in DBP and HR were observed at 6 weeks, without further increases up to 6 months’ follow-up. A small but statistically significant increase in SBP was observed over time. Twenty-nine percent of patients had isolated elevations in BP readings prior to study entry, and 14% had >3 consecutive visits at which elevated BP were observed during OROS MPH treatment. No clinically significant changes in ECG parameters were observed. No serious cardiovascular adverse events occurred. Conclusions: Treatment with relatively high doses of OROS MPH was associated with small but statistically significant mean increases in BP and HR, primarily during the first 6 weeks of treatment, without clinically meaningful changes in ECG. These observations are consistent with previous reports using lower doses. [Copyright &y& Elsevier]

Paul Hammerness, Katherine McCarthy, Elizabeth Mancuso, Cassandra Gendron, Daniel GellerClinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital and Harvard Medical School, Cambridge, MA, USAObjective: This review examines and summarizes the pharmacodynamic and pharmacokinetic properties, short- and longer-term efficacy, the moderating effect of comorbid disorders, as well as short- and long-term safety and tolerability of atomoxetine for the treatment of pediatric attention-deficit/hyperactivity disorder (ADHD).Methods: A systematic literature search was performed to review the extant literature on articles pertaining to the pharmacological treatment with atomoxetine in pediatric and/or adolescent ADHD.Results: There is an extensive literature on atomoxetine; over 4000 children have participated in clinical trials of atomoxetine, demonstrating its short- and longer-term efficacy. In addition, studies have examined the moderating effect of comorbid disorders on atomoxetine response, as well as atomoxetine’s therapeutic potential for other psychiatric conditions. Short- and longer-term safety and tolerability continue to be reported.Conclusions: Atomoxetine is indicated for both acute and maintenance/extended treatment of pediatric ADHD. Clinicians and families must be familiar with atomoxetine’s evidence base, including its profile of clinical response and its possible effectiveness in the presence of comorbidity.Keywords: ADHD, atomoxetine, pediatric

Joseph Biederman, Paul Hammerness, Robert Doyle, Gagan Joshi, Megan Aleardi, Eric MickPediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston, MA, USAObjective: Children and adolescents with bipolar disorder are also at high risk of having comorbid attention-deficit hyperactivity disorder (ADHD). The objective of this study was to estimate improvement in ADHD symptoms in children with bipolar disorder.Methods: This was an open-label, study of risperidone monotherapy for the treatment of pediatric bipolar disorder. Thirty-one children and adolescents 4–15 years of age (7.2 ± 2.8 years) of both sexes (71%, N = 22 male) with pediatric bipolar disorder (YMRS score = 32.9 ± 8.8) and ADHD (ADHD-RS score = 37.9 ± 8.9) were included in these analyses.Results: Improvement in ADHD symptoms was contingent on improvement in manic symptoms. Although both hyperactive/impulsive (−7.5 ± 5.5.6, p < 0.05) and inattentive (−6.8 ± 5.0, p < 0.05) ADHD symptoms were significantly improved with risperidone, improvement was modest, and only 29% of subjects (N = 6) showed a 30% reduction in ADHD rating scale scores and had a CGI-I ≤ 2.Conclusions: These results suggest that that treatment with risperidone is associated with tangible but generally modest improvement of symptoms of ADHD in children with bipolar disorder.Keywords: ADHD, bipolar disorder, children, risperidone

This paper draws upon recent research on program features that characterize powerful teacher education. Based upon research and scholarship in the U.S., suggests that teacher education programs need to promote a clear vision of teachers and teaching; must be coherent, reflecting a shared understanding of teaching and learning among faculty and students; and finally, that they need to be built around a strong core curriculum deeply tied to teaching practice. However, we know little about whether these features also characterize powerful teacher education programs in other countries. To start to address that gap, I describe research from two separate studies, one conducted in the United States and one in Norway. Both studies examined the visions, coherence, and relationship to practice in a range of teacher education programs. In this second paper, I share the findings from the Norwegian study. An opportunity to look across two contexts at the same features helps provide some initial insights about key characteristics of teacher education that may matter most.

This paper draws upon recent research on program features that characterize powerful teacher education. This research suggests that teacher education programs need to promote a clear vision of teachers and teaching; must be coherent, reflecting a shared understanding of teaching and learning among faculty and students; and finally, need to be built around a strong core curriculum deeply tied to teaching practice. However, we know little about whether these features also characterize powerful teacher education programs in other countries. To address that gap, I share research from two studies, one in the United States, and one in Norway (in the linked paper that follows). The studies examined the visions, coherence, and relationship to practice in a range of teacher education programs. This first paper examines the nature and role of vision, coherence and opportunities to learn in three teacher education programs in the United States.

Purpose of Review: To provide an up-to-date clinical review of U.S. Food and Drug Administration (FDA)-approved stimulant medications for attention-deficit/hyperactivity disorder (ADHD), including a framework for individualized treatment by primary care pediatric providers., Recent Findings: Stimulant medications are first-line agents for pediatric ADHD. Since 2012, 11 novel stimulant medications have been approved by the FDA for the treatment of ADHD. Because of an expanded formulary of available methylphenidate-based and amphetamine-based stimulants, primary care providers may be unfamiliar with some novel medications outside a select formulary., Summary: The current broad formulary of methylphenidate-based and amphetamine-based stimulants provides primary care clinicians with a greater opportunity for personalized medicine within the patient-centered medical home. Through a systematic review of prior relevant medication trials, a consideration of daily symptom burden and thoughtful pragmatics, primary care providers can offer a more precise, customized stimulant treatment.