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      Efficacy and Safety of Dasotraline in Children With ADHD: A Laboratory Classroom Study

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          Abstract

          Objective: To evaluate the efficacy and safety of dasotraline for treatment of ADHD in children. Method: Children (ages 6-12 years; N = 112) with ADHD were randomized, double-blind, to 14 days of once-daily evening doses of dasotraline 4 mg or placebo. ADHD symptom severity was measured at baseline and Day 15 in seven, 30-min classroom sessions using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) and the Permanent Product Measure of Performance (PERMP) math test. Results: Significant improvement was observed for dasotraline versus placebo in the SKAMP-combined score (−3.2 vs. +2.0; p < .001; effect size = 0.85) and SKAMP and PERMP subscale scores. The three most common adverse events for dasotraline (vs. placebo) were insomnia (19.6% vs. 3.6%), headache (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%). Conclusion: In this laboratory classroom study, dasotraline 4 mg was found to be an efficacious and generally well-tolerated treatment for ADHD in children aged 6 to 12 years.

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          A power primer.

          One possible reason for the continued neglect of statistical power analysis in research in the behavioral sciences is the inaccessibility of or difficulty with the standard material. A convenient, although not comprehensive, presentation of required sample sizes is provided here. Effect-size indexes and conventional values for these are given for operationally defined small, medium, and large effects. The sample sizes necessary for .80 power to detect effects at these levels are tabled for eight standard statistical tests: (a) the difference between independent means, (b) the significance of a product-moment correlation, (c) the difference between independent rs, (d) the sign test, (e) the difference between independent proportions, (f) chi-square tests for goodness of fit and contingency tables, (g) one-way analysis of variance, and (h) the significance of a multiple or multiple partial correlation.
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            The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults.

            Research on suicide prevention and interventions requires a standard method for assessing both suicidal ideation and behavior to identify those at risk and to track treatment response. The Columbia-Suicide Severity Rating Scale (C-SSRS) was designed to quantify the severity of suicidal ideation and behavior. The authors examined the psychometric properties of the scale. The C-SSRS's validity relative to other measures of suicidal ideation and behavior and the internal consistency of its intensity of ideation subscale were analyzed in three multisite studies: a treatment study of adolescent suicide attempters (N=124); a medication efficacy trial with depressed adolescents (N=312); and a study of adults presenting to an emergency department for psychiatric reasons (N=237). The C-SSRS demonstrated good convergent and divergent validity with other multi-informant suicidal ideation and behavior scales and had high sensitivity and specificity for suicidal behavior classifications compared with another behavior scale and an independent suicide evaluation board. Both the ideation and behavior subscales were sensitive to change over time. The intensity of ideation subscale demonstrated moderate to strong internal consistency. In the adolescent suicide attempters study, worst-point lifetime suicidal ideation on the C-SSRS predicted suicide attempts during the study, whereas the Scale for Suicide Ideation did not. Participants with the two highest levels of ideation severity (intent or intent with plan) at baseline had higher odds for attempting suicide during the study. These findings suggest that the C-SSRS is suitable for assessment of suicidal ideation and behavior in clinical and research settings.
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              Prevalence of attention-deficit/hyperactivity disorder: a systematic review and meta-analysis.

              Overdiagnosis and underdiagnosis of attention-deficit/hyperactivity disorder (ADHD) are widely debated, fueled by variations in prevalence estimates across countries, time, and broadening diagnostic criteria. We conducted a meta-analysis to: establish a benchmark pooled prevalence for ADHD; examine whether estimates have increased with publication of different editions of the Diagnostic and Statistical Manual of Mental Disorders (DSM); and explore the effect of study features on prevalence.
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                Author and article information

                Journal
                J Atten Disord
                J Atten Disord
                JAD
                spjad
                Journal of Attention Disorders
                SAGE Publications (Sage CA: Los Angeles, CA )
                1087-0547
                1557-1246
                2 August 2019
                January 2020
                : 24
                : 2 , Special Issue on Medication Treatment in Children with ADHD
                : 192-204
                Affiliations
                [1 ]AVIDA Inc., Newport Beach, CA, USA
                [2 ]Sunovion Pharmaceuticals Inc., Marlborough, MA, USA
                [3 ]Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA
                Author notes
                [*]Robert Goldman, Sunovion Pharmaceuticals, Inc., 84 Waterford Drive, Marlborough, MA 01752-7010, USA. Email: robert.goldman@ 123456sunovion.com
                Article
                10.1177_1087054719864644
                10.1177/1087054719864644
                8129465
                31375051
                7a401a9f-6351-4e62-8980-3e56227b5387
                © The Author(s) 2019

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                Funding
                Funded by: sunovion, FundRef https://doi.org/10.13039/100009655;
                Categories
                Current Perspectives
                Custom metadata
                ts1

                adhd,dasotraline,randomized controlled trial,children
                adhd, dasotraline, randomized controlled trial, children

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