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Objective: To assess the effect of atomoxetine on ADHD-related executive functions over a 6-month period using the Brown Attention-Deficit Disorder Scale (BADDS) for Adults, a normed, 40-item, self-report scale in a randomized, double-blind, placebo-controlled clinical trial. Method: In a randomized, double-blind clinical trial, adults with ADHD received either atomoxetine 25 to 100 mg/day or placebo for 6 months. Patients completed the BADDS to report their current daily functioning in 5 clusters of ADHD-related impairments of executive functioning: (1) Organizing and Activating to Work; (2) Focusing for Tasks; (3) Regulating Alertness and Effort; (4) Modulating Emotions; and (5) Utilizing Working Memory. Results: Mean scores were significantly more improved in the atomoxetine group compared to the placebo group: total score, -27.0 versus -19.0 (p less than 0.001); all 5 cluster scores, p less than 0.01. Conclusions: Once-daily atomoxetine can improve executive function impairments in adults with ADHD as assessed by the BADDS. (Contains 2 tables and 2 figures.)

Objective: To assess the utility and tolerability of higher than standard atomoxetine doses to treat attention-deficit/hyperactivity disorder (ADHD). Method: Two randomized, double-blind trials of atomoxetine nonresponders ages 6 to 16 years were conducted comparing continued treatment with same-dose atomoxetine to treatment using greater than standard efficacious doses (study 1: up to 3.0 mg x kg[superscript -1] x day [superscript -1]; study 2: up to 2.4 mg x kg[superscript -1] x day[superscript -1]. Results: The primary outcome measure for both studies was mean ADHD Rating Scale (ADHD RS) total score. For study 1 (N = 122), decreases in ADHD RS total scores were not significantly different between treatment groups (mean change [SD]: continued same dose, -8.9 [11.2]; high dose, -9.8 [13.1]; p = 0.595). Likewise, for study 2 (N =125), treatment groups did not differ (mean change [SD]: continued same dose, -6.2 [12.2]; high dose, -8.9 [10.0], p = 0.110). Tolerability was not significantly different between the continued same-dose and high-dose groups. Conclusions: These studies provide evidence that current dose recommendations are appropriate for most patients,suggesting no systematic advantage to increasing atomoxetine doses beyond current guidelines. In both studies, continued treatment, whether at a higher dose or the previous dose, was associated with improved outcomes in patients who demonstrated incomplete/inadequate response to acute ADD treatment, although without a placebo arm, we cannot rule out the possibility that expectancy played a role in symptom improvement. (Contains 2 figures and 4 tables.)

The purpose of the study was to evaluate the impact of the Going Places Program and mediation of treatment effects. Seven middle schools were randomized to intervention or comparison conditions and students (n = 1,320) in two successive cohorts provided five waves of data from sixth through eighth grade. The Going Places Program included classroom curriculum, parent education, and school environment components. Latent growth curve analyses demonstrated significant treatment group effects on outcome expectancies, friends who smoke, and smoking. Friends who smoke mediated the program effect on adolescents' smoking progression. The protective effect of the Going Places Program on smoking progression was due in part to the prevention of increases in friends who smoke. (Contains 1 table and 4 figures.)

Surveyed middle school students on incidents of bullying and victimization. Found that psychosocial and behavioral predictors such as problem behaviors, attitudes toward deviance, peer influences, depressive symptoms, school-related functioning, and parenting linearly separated never bullied or victimized students from the victim group, from the bully group, and from the bully/victim group. (DLH)

Objective: The objective of this study is to evaluate efficacy and safety of SPN-812 (extended-release viloxazine) for ADHD in children aged 6 to 12 years. Method: In an 8-week study, 222 participants were randomized to placebo or SPN-812 100, 200, 300, or 400 mg/day. Measurements included ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores. Safety assessments included laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting. Results: Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo (p <.05; effect size [ES] = 0.547, 0.596, and 0.623). CGI-I score for the 300 mg group and CGI-S score for all SPN-812 groups except for 100 mg improved significantly (p <.05) versus placebo. The most frequent AEs (≥15%) were somnolence, headache, and decreased appetite. Conclusion: SPN-812 significantly reduced the severity of ADHD symptoms and was well tolerated. The efficacy and safety of SPN-812 are being investigated in Phase III trials. [ABSTRACT FROM AUTHOR]

Objective: This article examines the characteristics of impulsive aggression (IA) as a comorbidity in children and adolescents with attention-deficit/hyperactivity disorder (ADHD), focusing on its incidence, impact on ADHD outcomes, need for timely intervention, and limitations of current treatment practices.Methods: Relevant literature was retrieved with electronic searches in PubMed and PsycINFO using the search strategy of "ADHD OR attention deficit hyperactivity disorder" AND "impulsive aggression OR reactive aggression OR hostile aggression OR overt aggression" AND "pediatric OR childhood OR children OR pre-adolescent OR adolescent" with separate searches using review OR clinical trial as search limits. Key articles published before the 2007 Expert Consensus Report on IA were identified using citation analysis.Results: More than 50% of preadolescents with ADHD combined subtype reportedly display clinically significant aggression, with impulsive aggression being the predominant subtype. Impulsive aggression is strongly predictive of a highly unfavorable developmental trajectory characterized by the potential for persistent ADHD, increasing psychosocial burden, accumulating comorbidities, serious lifelong functional deficits across a broad range of domains, delinquency/criminality, and adult antisocial behavior. Impulsive aggression, which triggers peer rejection and a vicious cycle of escalating dysfunction, may be a key factor in unfavorable psychosocial outcomes attributed to ADHD. Because severe aggressive behavior does not remit in many children when treated with primary ADHD therapy (i.e., stimulants and behavioral therapy), a common practice is to add medication of a different class to specifically target aggressive behavior.Conclusions: Impulsive aggression in children and adolescents with ADHD is a serious clinical and public health problem. Although adjunctive therapy with an aggression-targeted agent is widely recommended when aggressive behaviors do not remit with primary ADHD therapy, empirical evidence does not currently support the use of any specific agent. Randomized controlled trials are needed to identify aggression-targeted agents with favorable benefit-risk profiles. [ABSTRACT FROM AUTHOR]

Objectives. Atomoxetine seems to be as effective for treating attention-deficit/hyperactivity disorder (ADHD) when the daily dose is administered once in the morning as when the dose is divided and administered in the morning and evening. In the present study, the efficacy of atomoxetine administered once daily among children with ADHD was assessed throughout the day, including the evening and early morning. Another goal was to determine how early in treatment it was possible to discern a specific effect of the drug on ADHD symptoms. Methods. This study was a randomized, multicenter, double-blind, placebo-controlled trial conducted at 12 outpatient sites in the United States. A total of 197 children, 6 to 12 years of age, who had been diagnosed as having ADHD, on the basis of the Diagnostic and Statistical Manual of Mental Disorders (4th ed.) criteria, were randomized to receive 8 weeks of treatment with atomoxetine or placebo, dosed once daily in the mornings. ADHD symptoms were assessed with parent and investigator rating scales. The primary outcome measure was the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored total score. Daily parent assessments of children&apos;s home behaviors in the evening and early morning were recorded with an electronic data entry system. This instrument measures 11 specific morning or evening activities, including getting up and out of bed, doing or completing homework, and sitting through dinner. Results. Seventy-one percent of the children enrolled were male, 69% met criteria for the combined subtype (both inattentive and hyperactive/impulsive symptoms), and the most common psychiatric comorbidity was oppositional defiant disorder (35%). Once-daily atomoxetine (final mean daily dose of 1.3 mg/kg) was significantly more effective than placebo in treating core symptoms of ADHD. Mean reductions in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored total score were significantly greater for patients randomized to atomoxetine, beginning at the first visit after the initiation of treatment and continuing at all subsequent visits. Both inattentive and hyperactive/impulsive symptom clusters were significantly reduced with atomoxetine, compared with placebo. With continued treatment and dose titrations, core symptoms of ADHD continued to decrease throughout the 8-week study. Mean reductions in the daily parent assessment total scores for patients randomized to atomoxetine were superior during the first week, beginning with the first day of dosing, and were also superior at endpoint. Efficacy outcomes for the evening hours for atomoxetine-treated patients were superior to those for placebo-treated patients, as assessed with 2 different assessment scales. Decreases in the daily parent assessment morning subscores at endpoint showed a significant reduction in symptoms that lasted into the mornings. Rates of discontinuations attributable to adverse events were Conclusions. Among children 6 to 12 of age who had been diagnosed as having ADHD, once-daily administration of atomoxetine in the morning provided safe, rapid, continuous, symptom relief that lasted not only into the evening hours but also into the morning hours. Atomoxetine treatment was safe and well tolerated. Pediatrics 2004;114:e1--e8. URL: http.//www.pediatrics.org/ cgi/content/full/114/1/el; atomoxetine, ADHD, children, continuous relief, once-daily, rapid onset of action.

Persistence of attention deficit hyperactivity disorder (ADHD) into adulthood can be disabling or lead to substantial impairment. Several clinical trials of atomoxetine (ATX) in adults with ADHD have been reported following the National Institute for Health and Clinical Excellence (NICE) guidelines issued in 2008. We performed an integrated analysis of all Eli Lilly-sponsored, randomized, double-blind, placebo-controlled studies of ATX in adults with ADHD completed as of May 2012. Individual patient data were pooled from six short-term (10–16 week) studies (1961 patients) and three longer-term (six-month) studies (1413 patients). In the short-term analysis, ATX patients achieved a significantly greater mean reduction in ADHD symptoms than placebo patients (−12.2 vs −8.1; Conners’ Adult ADHD Rating Scale–Investigator-Rated: Screening Version (CAARS-Inv: SV); p<0.001). In the longer-term analysis, respective improvements after six months were −13.2 vs −9.7 (p<0.001). Response rates at study endpoints for ATX vs placebo, based on CAARS-Inv: SV improvement ≥30% and Clinical Global Impressions of ADHD-Severity (CGI-ADHD-S) ≤3 were 34.8% vs 22.3% in the short-term and 43.4% vs 28.0% after six months, and CAARS-Inv: SV improvements ≥40% were 41.3% vs 25.3% in the short-term and 44.0% vs 31.4% after six months (all p<0.001). Overall, ATX had a clinically significant effect in adults with ADHD, with reductions in core symptoms and clinically meaningful responder rates. [ABSTRACT FROM AUTHOR]

Background This study examined the effects of lisdexamfetamine dimesylate (LDX) on quality of life (QOL) in adults with attention-deficit/hyperactivity disorder (ADHD) and clinically significant executive function deficits (EFD). Methods This report highlights QOL findings from a 10-week randomized placebo-controlled trial of LDX (30-70 mg/d) in adults (18-55 years) with ADHD and EFD (Behavior Rating Inventory of EF-Adult, Global Executive Composite [BRIEF-A GEC] ≥65). The primary efficacy measure was the self-reported BRIEF-A; a key secondary measure was self-reported QOL on the Adult ADHD Impact Module (AIM-A). The clinician-completed ADHD Rating Scale version IV (ADHD-RS-IV) with adult prompts and Clinical Global Impressions-Severity (CGI-S) were also employed. The Adult ADHD QoL (AAQoL) was added while the study was in progress. A post hoc analysis examined the subgroup having evaluable results from both AIM-A and AAQoL. Results Of 161 randomized (placebo, 81; LDX, 80), 159 were included in the safety population. LDX improved AIM-A multi-item domain scores versus placebo; LS mean difference for Performance and Daily Functioning was 21.6 (ES, 0.93, P<.0001); Impact of Symptoms: Daily Interference was 14.9 (ES, 0.62, P<.0001); Impact of Symptoms: Bother/Concern was 13.5 (ES, 0.57, P=.0003); Relationships/Communication was 7.8 (ES, 0.31, P=.0302); Living With ADHD was 9.1 (ES, 0.79, P<.0001); and General Well-Being was 10.8 (ES, 0.70, P<.0001). AAQoL LS mean difference for total score was 21.0; for subscale: Life Productivity was 21.0; Psychological Health was 12.1; Life Outlook was 12.5; and Relationships was 7.3. In a post hoc analysis of participants with both AIM-A and AAQoL scores, AIM-A multi-item subgroup analysis scores numerically improved with LDX, with smaller difference for Impact of Symptoms: Daily Interference. The safety profile of LDX was consistent with amphetamine use in previous studies. Conclusions Overall, adults with ADHD/EFD exhibited self-reported improvement on QOL, using the AIM-A and AAQoL scales in line with medium/large ES; these improvements were paralleled by improvements in EF and ADHD symptoms. The safety profile of LDX was similar to previous studies. [ABSTRACT FROM AUTHOR]

Social influences can promote or discourage adolescent substance use. The authors surveyed 4,263 sixth- to eighth-grade students to assess the effect of peer and parent influences on adolescent substance use. The authors conducted separate multiple logistic regression analyses for smoking and drinking, controlling for grade, sex, and race. Positive independent associations with smoking and drinking were found for direct peer pressure and associating with problem-behaving friends. Independent negative associations with smoking and drinking were also found for parent involvement, parent expectations, and parent regard. In an analysis of interactions, peer pressure was positively associated with drinking for girls but not for boys and problem-behaving friends was positively associated with drinking for both boys and girls. The findings are consistent with the hypothesis that associating with deviant peers promotes and that authoritative parenting protects against smoking and drinking. [ABSTRACT FROM AUTHOR]

A survey of 1728 tenth grade students was conducted to assess the prevalence of purging behavior, alcohol and drug use, and reported physical and psychological distress. Thirteen percent reported purging behavior. Female purgers outnumbered males 2 to 1. Male purgers were significantly heavier than male nonpurgers. The prevalence of drunkenness and daytime drinking among female purgers was significantly higher than for female nonpurgers. Female purgers were more likely to report using alcohol to reduce stress than nonpurging female peers. Female purgers reported a higher level of psychological distress when perceived situational control is low than female nonpurgers. Significant differences were not Found between male purgers and male nonpurgers on variables assessing alcohol use and psychological distress. Educational programs aimed at prevention of eating disorders may need to be developed. [ABSTRACT FROM AUTHOR]

Laxative abuse is an increasingly popular weight-loss method on college campuses, particularly for individuals with eating disorders. It is a dangerous habit, which many mistakenly believe will prevent caloric absorption and weight gain. Serious medical problems that may occur with laxative abuse include electrolyte and fluid imbalance, structural and functional colonic changes, and allergic reactions. Because patients are often secretive about abusing laxatives, laxative abuse should be considered if there is suspicion about the use of potentially destructive weight-control methods or about an eating disorder. A complete history and physical exam are essential parts of an assessment that should also include questions about diet, eating and exercise habits, and body image. Laboratory tests may provide additional supportive data. Treatment includes education, discontinuation of laxatives, medical follow-up as necessary, and psychotherapy. A college campus is an ideal forum for education, referral, and prevention programs. [ABSTRACT FROM AUTHOR]

Abstract: We surveyed 646 tenth grade females in Northern California to assess the prevalence of binge eating and purging behaviors. Of these, 10.3 per ¢ met study criteria for bulimia and an additional 10.4 per ¢ reported purging behaviors for weight control. Bulimics and purgers were heavier, had greater triceps and subscapular skinfold thicknesses, and reported higher rates of drunkenness, marijuana use, cigarette use. and greater levels of depressive symptomatology. (Am J Public Health 1987: 77:1539-1541.) [ABSTRACT FROM AUTHOR]

Presents a letter to the editor of the April 16, 1989 issue of the 'Journal of the American Medical Association,' about the abuse of benzodiazepines by patients receiving methadone maintenance.

Objective: This study measured the effects of atomoxetine HCl on high-risk behaviors and health-related quality of life in adolescents with attention-deficit/hyperactivity disorder (ADHD), using a subgroup analysis of data from a previous clinical trial., Research Design and Methods: In the base study, which was conducted at 26 sites in the United States, patients ages 13-16 years were randomized in a double-blind manner to atomoxetine treatment by one of two dose titration schedules for 8 weeks. Patients who responded to treatment were rerandomized to atomoxetine at a daily dose of 0.8 or 1.4 mg/kg for 40 weeks. Patients in the highest-risk quartile for each category of behavior or domain were included and the dosing groups combined., Main Outcome Measures: Efficacy measures included the Youth Risk Behavior Surveillance (YRBS) and Child Health and Illness Profile - Adolescent Edition (CHIP-AE). The YRBS has six categories of behavior, and the CHIP-AE has six domains. Data for mean change from baseline were analyzed using a last-observation-carried-forward analysis., Results: A total of 267 patients were randomized, but the high-risk subgroup analyzed in the present study was much smaller (range of n = 5-68 per group). YRBS scores for tobacco use, unhealthful dietary behaviors, inadequate physical activity, and behaviors contributing to unintentional injuries showed statistically significant improvements (p < 0.05) by atomoxetine treatment at Week 8. At the end of the 40-week maintenance period, unhealthful dietary behaviors, inadequate physical activity, and behaviors contributing to unintentional injuries continued to show statistically significant improvements (p < 0.001). When the highest-risk quartile of the CHIP-AE data was analyzed, there were statistically significant improvements on all six domains after atomoxetine treatment at 8 weeks (p < 0.001) and on five of the six domains at 40 weeks (p < or = 0.01)., Conclusions: Atomoxetine improved self-reported high-risk behaviors and overall health-related quality of life in adolescents with ADHD. Potential limitations of this study include small sample sizes and the fact that it involved a subgroup analysis, which is by nature hypothesis-generating. Further, well-controlled, prospective studies in larger and more heterogeneous ADHD populations, including older patients, are warranted to confirm or reject these findings.

Introduction: The Life Participation Scale for Attention-Deficit/Hyperactivity Disorder (ADHD)-Child Version (LPS-C) was developed to capture treatment-related improvements in adaptive functioning, including quality of life, social development, and emotion regulation, that may be missed by scales that assess only the 18 ADHD symptoms in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). The 24-item LPS-C is intended to augment traditional ADHD measures. This analysis assessed the scale's psychometric properties., Methods: The LPS-C was completed by the investigators while questioning the parents of 979 children in three placebo-controlled clinical trials that measured the effects of atomoxetine for treating ADHD. In addition to a factor analysis, assessments of responsiveness; internal consistency; item-to-total correlations; and convergent, divergent, and discriminant validity were completed., Results: The LPS-C showed evidence of internal consistency and convergent, divergent, and discriminant validity. The factor analysis suggested two subscales (labeled the Self-Control and Agreeable subscales). The LPS-C demonstrated responsiveness in two of the three trials. The effect sizes suggest responsiveness between that for psychosocial measures and core symptom measures., Conclusions: The LPS-C appears to be a valid research and clinical instrument for assessing change in ADHD-related adaptive functioning that may not be captured by traditional measures of core ADHD symptoms.

Objective: To examine the effects on growth of long-term pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD), we present findings from an ongoing 5-year study of the efficacy and safety of treatment with atomoxetine., Methods: North American patients, 6-17 years old at study entry (N = 1,312) and with Diagnostic and Statistical Manual of Mental Disorders,4th edition (DSM-IV) ADHD, were studied under open-label atomoxetine treatment. Sixty-one were studied up to 5 years., Results: After 1 month's treatment, patients weighed less than expected from their starting percentiles relative to population norms, with a maximum shortfall at 15 months and a return to expected weight by 36 months. Patients were slightly shorter than expected after 12 months, reaching a maximum shortfall at 18 months and returning to expected height by 24 months. Patients in the top quartile for body mass index (BMI) or weight at baseline, and those in the third quartile for height, showed 5-year decreases from expected values. Those below median height at baseline showed increases relative to expected values., Conclusions: These interim results indicate that continuous atomoxetine treatment for up to 5 years has little or no long-term effect on juvenile growth and final stature for most patients, although persistent decreases from expected may occur in some patients who are larger than average before treatment.

The DSM-IV diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) have proved useful in providing a common language for diagnosing, treating, and researching the disorder. Despite the utility of current ADHD diagnostic criteria, sophisticated theoretical conceptualizations of the etiology of ADHD have described a much more complex disorder that includes a range of neuropsychological impairments (such as working memory deficits and other executive dysfunction) and underlying structural and functional neuropathology (e.g., caudate nucleus volume, frontal lobe activity). Inattention, hyperactivity, and impulsivity, the hallmark triumvirate symptoms of ADHD, may be better viewed as some of the many meaningful symptoms with roots in executive-functioning impairment. Outcomes of brain-imaging studies, public skepticism about diagnosis and treatment, and a demand for meaningful clinical outcomes of treatment point to a considerable need to broaden treatment-outcome criteria beyond the DSM-IV domains. The wide-ranging decrements in adaptive function and quality of life reported by parents of children diagnosed with ADHD further support core executive dysfunction. Emerging findings concerning medication-related improvements in adaptive functioning (e.g., social, emotional, academic), as well as the rapid search for the neuropathology that may underlie these improvements, are fueling interest in the assessment of adaptive function in clinical trials. In a series of ongoing clinical trials of a novel nonstimulant medication for ADHD, many parents reported significant improvements in the lives of their children beyond the DSM-IV criteria. These parental reports, despite their inherent sources of error, underscore the importance of including broader and more meaningful clinical outcome assessment in clinical trials. Research protocols that omit parental interviews that assess adaptive and executive function may well overlook several meaningful and consequential medication-related improvements.