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Pilot Study of Prism EFP NeuroFeedback in Adult ADHD

Adler, Lenard A.; Anbarasan, Deepti; Leon, Terry; Sardoff, Taylor; Descorbeth, Olivia; Cho, Dayeon; Stern, Yaki; Kraft, Oded; Hendler, Talma; Marmar, Charles R.
Objective: A pilot study to preliminarily examine the effects of Prism EFP NeuroFeedback (NF) in adult ADHD. Method: Prism EFP NF is a form of NF specifically designed to target emotional dysregulation (ED) through down regulation of amygdala activity. Prism EFP NF has been shown to improve other disorders with significant ED. Nine participants with adult ADHD received an open trial of Prism EFP NF consisting of fifteen sessions over 8 weeks; all completed at least 5 weeks of treatment with seven completing all 8 weeks. Outcomes were assessed by change in ADHD symptoms from baseline to End of Treatment. Results: About two-third reduction was seen in total DSM ADHD symptom scores (primary outcome measure) with improvement observed in all other clinical measures. No significant adverse events were seen. Conclusion: This preliminary trial found substantial effects of Prism EFP NF on ADHD/ED symptoms and global impairment.
SCOPUS:85181227103
ISSN: 1087-0547
CID: 5630972

Efficacy, Safety, and Tolerability of Centanafadine Sustained-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder: Results of 2 Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Trials

Adler, Lenard A; Adams, Julie; Madera-McDonough, Jessica; Kohegyi, Eva; Hobart, Mary; Chang, Denise; Angelicola, Mark; McQuade, Robert; Liebowitz, Michael
PURPOSE/BACKGROUND/OBJECTIVE:Centanafadine is an inhibitor of norepinephrine, dopamine, and serotonin reuptake transporters under investigation for the treatment of attention-deficit/hyperactivity disorder (ADHD). METHODS/PROCEDURES/METHODS:Two phase 3 randomized, double-blind, placebo-controlled, parallel-group studies of 200 mg/d or 400 mg/d centanafadine sustained-release tablets versus placebo included adults (18-55 years of age) with a diagnosis of ADHD. The primary and key secondary efficacy endpoints were the change from baseline at day 42 in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score and the Clinical Global Impression-Severity of Illness Scale, respectively. FINDINGS/RESULTS/RESULTS:Subjects randomized in study 1 (centanafadine 200 mg/d, n = 149; centanafadine 400 mg/d, n = 149; placebo, n = 148) and study 2 (centanafadine 200 mg/d, n = 145; centanafadine 400 mg/d, n = 143; placebo, n = 142) had moderate to severe ADHD (mean AISRS total score, 38.7 [SD, 6.8] across both studies). At day 42, statistically significant least-squares mean differences in AISRS total score were observed in favor of centanafadine versus placebo in study 1 (200 mg/d: -3.16, P = 0.019; 400 mg/d: -2.74, P = 0.039) and study 2 (200 mg/d: -4.01, P = 0.002; 400 mg/d: -4.47, P = 0.001). Effect sizes versus placebo were -0.28 for 200 mg/d and -0.24 for 400 mg/d in study 1 and -0.37 for 200 mg/d and -0.40 for 400 mg/d in study 2. The overall rate of treatment-emergent adverse events (TEAEs) was low, but there was a small increase in TEAE occurrence with increasing dose. Incidences of serious TEAEs and abuse potential-related AEs were low. IMPLICATIONS/CONCLUSIONS/CONCLUSIONS:These are the first large-scale studies to demonstrate the efficacy and safety profiles of 200 mg/d and 400 mg/d centanafadine in adults with ADHD.
PMID: 35652746
ISSN: 1533-712x
CID: 5283532

Updates in Pharmacologic Strategies in Adult Attention-Deficit/Hyperactivity Disorder

Anbarasan, Deepti; Safyer, Gabriella; Adler, Lenard A
Attention-deficit/hyperactivity disorder (ADHD) significantly worsens quality of life and long-term functional outcomes in adults. Individual impairments in adults with ADHD can be further contextualized within considerable costs to society at large. Food and Drug Administration (FDA) approved stimulants and nonstimulant medications can significantly improve ADHD symptoms in adults. In the past 2 decades, the United States FDA has expanded approval of pharmacotherapeutic options for adult ADHD. However, limitations still persist in available psychotropics for certain patient populations such as those with comorbid substance use or cardiovascular illness. Clinicians therefore must appreciate several ongoing investigations into medications with unique mechanisms of action. This article reviews the current FDA approved and emerging medication options while providing guidelines for pharmacologic management of adult ADHD.
PMID: 35697401
ISSN: 1558-0490
CID: 5282562

Economic burden of attention-deficit/hyperactivity disorder among children and adolescents in the United States: a societal perspective

Schein, Jeff; Adler, Lenard A; Childress, Ann; Cloutier, Martin; Gagnon-Sanschagrin, Patrick; Davidson, Mikhaïl; Kinkead, Frédéric; Guerin, Annie; Lefebvre, Patrick
OBJECTIVE/UNASSIGNED:To provide a comprehensive evaluation of the economic burden associated with attention-deficit/hyperactivity disorder (ADHD) among children and adolescents from a US societal perspective. MATERIALS AND METHODS/UNASSIGNED:Direct healthcare costs of children (5-11 years) and adolescents (12-17 years) with ADHD were obtained using claims data from the IBM MarketScan Research Databases (01/01/2017-12/31/2018). Direct non-healthcare and indirect costs were estimated based on literature and government publications. Each cost component was estimated using a prevalence-based approach, with per-patient costs extrapolated to the national level. RESULTS/UNASSIGNED:The total annual societal excess costs associated with ADHD were estimated at $19.4 billion among children ($6,799 per child) and $13.8 billion among adolescents ($8,349 per adolescent). Education costs contributed to approximately half of the total excess costs in both populations ($11.6 billion [59.9%] in children; $6.7 billion [48.8%] in adolescents). Other major contributors to the overall burden were direct healthcare costs ($5.0 billion [25.9%] in children; $4.0 billion [29.0%] in adolescents) and caregiving costs ($2.7 billion [14.1%] in children; $1.6 billion [11.5%] in adolescents). LIMITATIONS/UNASSIGNED:Cost estimates were calculated based on available literature and/or governmental publications due to the absence of a single data source for all costs associated with ADHD. Thus, the quality of cost estimates is limited by the accuracy of available data as well as the study populations and methodologies used by different studies. CONCLUSION/UNASSIGNED:ADHD in children and adolescents is associated with a substantial economic burden that is largely driven by education costs, followed by direct healthcare costs and caregiver costs. Improved intervention strategies and policies may reduce the clinical and economic burden of ADHD in these populations.
PMID: 35068300
ISSN: 1941-837x
CID: 5154282

Economic burden of attention-deficit/hyperactivity disorder among adults in the United States: a societal perspective

Schein, Jeff; Adler, Lenard A; Childress, Ann; Gagnon-Sanschagrin, Patrick; Davidson, Mikhaïl; Kinkead, Frédéric; Cloutier, Martin; Guérin, Annie; Lefebvre, Patrick
PMID: 34806909
ISSN: 2376-1032
CID: 5063342

The Validity of the World Health Organization Adult Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition in Adolescence

Somma, Antonella; Adler, Lenard A; Gialdi, Giulia; Arteconi, Martina; Cotilli, Elisabetta; Fossati, Andrea
PMID: 34166067
ISSN: 1557-8992
CID: 5060842

Neurobiological Basis of Reinforcement-Based Decision-Making in Adults With ADHD Treated With Lisdexamfetamine Dimesylate

Ivanov, I; Newcorn, J H; Krone, B; Li, X; Duhoux, S; White, S F; Schulz, K P; Bédard, A C V; Pedraza, J; Adler, L A; Blair, R J
PMID: 34355611
ISSN: 1557-1246
CID: 5004282

A Placebo-Controlled Trial of Lisdexamfetamine in the Treatment of Comorbid Sluggish Cognitive Tempo and Adult ADHD

Adler, Lenard A; Leon, Terry L; Sardoff, Taylor M; Krone, Beth; Faraone, Stephen V; Silverstein, Michael J; Newcorn, Jeffrey H
PMID: 34232582
ISSN: 1555-2101
CID: 5043582

Dasotraline in adults with attention deficit hyperactivity disorder: a placebo-controlled, fixed-dose trial

Adler, Lenard A; Goldman, Robert; Hopkins, Seth C; Koblan, Kenneth S; Kent, Justine; Hsu, Jay; Loebel, Antony
In a previous study, dasotraline demonstrated efficacy at a dose of 8 mg/day in adults with attention deficit hyperactivity disorder (ADHD). The aim of the current study was to evaluate the efficacy and safety of dasotraline in doses of 4 and 6 mg/day. Adults meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria for ADHD were randomized to 8 weeks of double-blind, once-daily, fixed-dose treatment with dasotraline 4 mg/day, 6 mg/day, or placebo. The primary efficacy endpoint was changed in the ADHD Rating Scale, Version IV (ADHD RS-IV) total score. Secondary efficacy endpoints included the Clinical Global Impression, Severity (CGI-S) Scale. Least squares mean reduction at week 8 in the ADHD RS-IV HV total score was not significantly greater (vs. placebo) in the dasotraline 4 mg/day group (-15.0 vs. -13.9; n.s.; or in the dasotraline 6 mg/day group (-16.5 vs. -13.9; P = 0.074; Hochberg correction). Treatment with dasotraline 6 mg/day was significant at week 8 (uncorrected) on the ADHD RS-IV total score (P = 0.037) and the CGI-S score (P = 0.011). Treatment with the 4 mg/day dose of dasotraline was NS. Treatment with dasotraline was generally well tolerated. The results provide additional evidence that supports the potential efficacy of dasotraline, in doses of 6 mg/day, in adults with ADHD.
PMID: 33724251
ISSN: 1473-5857
CID: 4858252

Screening for Adult ADHD

Anbarasan, Deepti; Kitchin, Michael; Adler, Lenard A
PURPOSE OF REVIEW/OBJECTIVE:This review paper aims to update readers on the importance of screening for attention-deficit/hyperactivity disorder (ADHD) in adults and to provide a primer on how best to screen and diagnose this condition in an efficient and reliable manner. RECENT FINDINGS/RESULTS:The ASRS Screening Scale was updated in 2017 to reflect the changes made to identify ADHD based on the DSM-5 criteria and to reflect our understanding that adult ADHD is characterized by executive functioning deficits that are not explicitly reflected in the DSM-5 criteria. The use of the ASRS Screening Scale improves the clinician's ability to rapidly identify adult patients who require a comprehensive evaluation to diagnose ADHD and/or other comorbid psychiatric conditions. The scale has been validated for use in both the general population and in the ADHD specialty treatment population, which supports its use by both general clinicians and mental health clinicians. Identification of adult ADHD is critical due to the profound personal, familial, and societal costs associated with this condition.
PMID: 33095375
ISSN: 1535-1645
CID: 4642602