Search

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: 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]

Atomoxetine has been shown to be safe and effective in the treatment of attention-deficit/hyperactivity disorder (ADHD). The purpose of this post hoc analysis was to examine response trajectories of pediatric patients treated with atomoxetine. Data were pooled from 7 atomoxetine double-blind, placebo-controlled clinical trials conducted in pediatric patients between November 1998 and June 2004. Growth mixture modeling was applied to the investigator-rated ADHD rating scale (ADHDRS-Inv) and Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) scores in the randomized acute phase (6-9 weeks) to explore whether there were groups of patients who differed in their response to atomoxetine. Classification and regression tree analyses were performed to identify predictors that can help categorize subjects to different response profiles. Patients (N = 925) were mostly male (73%) and of the combined subtype (74%). Most patients had a response pattern characterized by gradual, modest improvement, while a smaller group experienced early, robust improvement. [ABSTRACT FROM AUTHOR]

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]

Data from 5 atomoxetine trials in pediatric outpatients with attention-deficit/hyperactivity disorder (ADHD) were divided into training and validation data sets to develop models predicting atomoxetine treatment response, using changes in individual ADHD Rating Scale (ADHD-RS) items early in treatment. Treatment response was predicted after 1 week by a ≥1-point score decrease in ADHD-RS item 15 ("easily distracted;" positive predictive values [PPVs]: 84.9%, 74.3%, and 73.3%; negative predictive values [NPVs]: 52.6%, 50.5%, and 46.3%; training and 2 validation data sets, respectively); after 2 to 3 weeks, by a ≥1-point score decrease in ADHD-RS item 1 ("fails to give close attention or makes careless mistakes;" PPV = 77.7% and 77.9%) and by the absence of a ≥1-point score decrease on ADHD-RS items 1 and 10 ("on the go;" NPV = 72.2% and 77.5%), or by the combination of items 1 and 10 (PPVs: 75.1% and 75.4%; NPVs: 72.2% and 77.5%; training and validation data sets, respectively). [ABSTRACT FROM AUTHOR]

The article presents a research on the going places program and mediation of treatment effects. This paper aims to evaluate the impact of the program evaluating the impact from seven middle schools. Evaluations were randomized to intervention or comparison conditions and students in successive cohorts from sixth to eighth grade. The program included classroom curriculum, parent education, and school environment components. It further examined the relation of friends who smoke on adolescents' smoking progression.

Objective: The authors assessed the efficacy of once-daily atomoxetine administration in the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD). Method: In a double-blind study, children and adolescents with ADHD (N = 171, age range = 6-16 years) were randomly assigned to receive 6 weeks of treatment with either atomoxetine (administered once daily) or placebo. Results: Outcomes among atomoxetinetreated patients were superior to those of the placebo treatment group as assessed by investigator, parent, and teacher ratings. The treatment effect size (0.71) was similar to those observed in previous atomoxetine studies that used twice-daily dosing. Parent diary ratings suggested that drug-specific effects were sustained late in the day. Discontinuations due to adverse events were low (less than 3%) for both treatment groups, and no serious safety concerns were observed. Conclusions: Once-daily administration of atomoxetine is an effective treatment for children and adolescents with ADHD. [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]

Bullying and victimization are prevalent problems in the area of adolescent peer relationships. Middle school students (N = 4,263) in one Maryland school district completed surveys covering a range of problem behaviors and psychosocial variables. Overall, 30.9% of the students reported being victimized three or more times in the past year and 7.4% reported bullying three or more times over the past year More than one half of the bullies also reported being victimized. Those bully/victims were found to score less favorably than either bullies or victims on all the measured psychosocial and behavioral variables. Results of a discriminant function analysis demonstrated that a group of psychosocial and behavioral predictors--including problem behaviors, attitudes toward deviance, peer influences, depressive symptoms, school-related functioning, and parenting--formed a linear separation between the comparison group (never bullied or victimized), the victim group, the bully group, and the bully/victim group. [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.