3 results
180 Efficacy of Dasotraline in Children With Attention Deficit Hyperactivity Disorder in a Laboratory Classroom Setting
- Robert Goldman, Ann Childress, Sharon B Wigal, Seth C Hopkins, Kenneth S Koblan, Kaushik Sarma, Jay Hsu, Antony Loebel
-
- Journal:
- CNS Spectrums / Volume 23 / Issue 1 / February 2018
- Published online by Cambridge University Press:
- 15 June 2018, p. 103
-
- Article
-
- You have access Access
- Export citation
-
Objectives
Once-daily dosing with dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, achieves stable plasma concentrations over 24 hours. This phase 3 study evaluated the efficacy and safety of dasotraline in children with attention deficithyperactivity disorder (ADHD) throughout the day, in a laboratory classroom setting (NCT02734693).
MethodsChildren (6–12 years) meeting DSM-5 criteria for ADHD were randomized to 2 weeks of dasotraline or placebo (dosed daily at home at approximately 8 PM). Following an abbreviated practice day, laboratory classroom evaluations took place at baseline and on Day 15. The primary endpoint was mean change from baseline at Day 15 in ADHD symptoms, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Combined Score (SKAMP-CS), obtained from the average of 7 assessments collected across the 12-hour laboratory classroom day (12–24 hours post-dose). Secondary endpoints included SKAMP scores obtained throughout the day at individual timepoints from 8 AM through 8 PM (12–24 hours post-dose), and measures of safety and tolerability.
ResultsThe ITT population comprised 112 patients. Mean age was 9.5 years, 68.8% were male; 92% completed the study. Dasotraline 4 mg/day significantly improved mean SKAMP-CS versus placebo (p<0.0001, effect size 0.85) with significant effects persisting throughout the day. Mean SKAMP subscores improved significantly versus placebo (Attention p<0.0001, effect size 0.81; Deportment p<0.001, effect size 0.70). Treatment-emergent adverse events were generally mild or moderate in severity; most frequent (with dasotraline 4 mg/day; placebo) included: insomnia (19.6%; 3.6%, all terms combined), decreased appetite (10.7%; 3.6%), headache (10.7%; 8.9%), affect lability (8.9%; 7.1%), irritability (5.4%; 3.6%), postural orthostatic tachycardia syndrome (5.4%; 0%), and perceptual disturbances (5.4%; 0%).
ConclusionsIn this 2-week, randomized, double-blind, laboratory classroom study in children with ADHD, once-daily dasotraline significantly improved ADHD symptoms (including deportment and attention), compared with placebo, and demonstrated sustained efficacyup to 24 hours post-dose. The most common adverse events were insomnia, decreased appetite, and headache.
Funding AcknowledgementsStudy sponsored by Sunovion Pharmaceuticals Inc.
Special Considerations in Diagnosing and Treating Attention-Deficit/Hyperactivity Disorder
- Sharon B. Wigal, Timothy L. Wigal
-
- Journal:
- CNS Spectrums / Volume 12 / Issue S9 / 2007
- Published online by Cambridge University Press:
- 07 November 2014, pp. 1-16
-
- Article
- Export citation
-
Attention-deficit/hyperactivity disorder (ADHD) is a prevalent chronic condition that affects people of all ages, including young children, school-aged children, adolescents, and adults. Symptoms can be noted as early as preschool age, tend to progress into functional impairment and behavioral problems in later childhood, and typically persist into adulthood. Contrary to previous belief, the disorder does not resolve with puberty for the majority of children; rather, the symptoms are manifested differently throughout the lifecycle. Presentation in adults is heavily biased toward inattentive symptoms, which are less likely to draw notice than hyperactive or impulsive symptoms and may contribute to the underrecognition of ADHD in this patient population. Diagnosis is particularly difficult due in large part to the pronounced comorbidity of psychiatric disorders in this patient population. Identification may be even more difficult in adults than children as the diagnostic criteria are not as clear, adults have difficulty remembering symptoms prior to 7 years of age, and there is a high prevalence of comorbid psychiatric disorders in adults. Early identification and treatment of symptoms of ADHD in preschool-age children is essential to effective long-term management of the disorder. Both medication and behavioral treatments appear to alleviate the symptoms of ADHD, and evidence suggests that discontinuation of treatment leads to the reemergence of the condition. Efforts are currently continuing toward understanding the genetic underpinnings of ADHD.
This expert review supplement will address the prevalence, comorbidity, treatment issues, and special considerations surrounding ADHD management throughout each stage of the lifecycle beginning with ADHD in preschool-aged children, continuing with school-aged children and adolescents, and ending with adulthood.
Pharmacologic Advances in the Treatment of ADHD
- Thomas J. Spencer, Sharon B. Wigal, Jeffrey H. Newcorn
-
- Journal:
- CNS Spectrums / Volume 7 / Issue 10 / October 2002
- Published online by Cambridge University Press:
- 07 November 2014, pp. 725-732
-
- Article
- Export citation
-
Attention-deficit/hyperactivity disorder (ADHD) is a common neuropsychiatric disorder that affects many domains of life. Studies have shown that adequate treatment of ADHD can affect the course of the disorder in a fundamental manner. While nonpharmacologic treatments such as education and various psycho-social interventions are used in the management of ADHD, pharmacotherapy is the mainstay of treatment for this disorder. Psychostimulants are the only group of agents that have been approved for the ADHD indication and are considered to be first-line treatment for the disorder. Methylphenidate, amphetamines, andpemoline are the most commonly used agents in this group. The stimulants have been successfully used for many years and their efficacy has been confirmed by a large number of clinical studies. Recent pharmacological advances have been made with longer-acting stimulants, new isomers, and more advanced drug delivery systems that enable more convenient dosing schedules with drug effects lasting throughout the day. Other nonstimulant medications have been shown to have anti-ADHD activity as well, although more research is needed on the efficacy and utility of these treatments. Antihypertensive medications and antidepressants, such as tricyclics and bupropion, have been studied and may have applications in the treatment of specific subgroups of patients with comorbid conditions or for patients who do not respond to stimulant treatment.