Predicting efficacy of viloxazine extended-release treatment in adults with ADHD using an early change in ADHD symptoms: Machine learning Post Hoc analysis of a phase 3 clinical trial.

Early response to viloxazine extended-release (viloxazine ER, Qelbree®) treatment predicted efficacy outcome in pediatric subjects with attention-deficit/hyperactivity disorder (ADHD). This study sought to determine whether the machine learning lasso model used in the pediatric study would predict response to viloxazine ER in an adult population based on early improvements in ADHD symptoms. We used data from a double-blind, placebo-controlled, flexible-dose (200-600 mg) study of viloxazine ER (N = 354; 18 to 60 years old).

The role of placebo response in the efficacy outcome assessment in viloxazine extended-release pivotal trials in paediatric subjects with attention-deficit/hyperactivity disorder.

Aims: Four Phase 3 studies evaluated efficacy and safety of viloxazine extended-release in the treatment of attention-deficit/hyperactivity disorder (ADHD). The primary efficacy objective-change from baseline in ADHD Rating Scale-5 (ADHD-RS-5) Total score at end of study (EOS)-was not met in one of the studies (812P304). A band-pass analysis was performed to evaluate the impact of placebo response on the results.

Viloxazine in the Management of CNS Disorders: A Historical Overview and Current Status.

Viloxazine has a long history of clinical use in Europe as an antidepressant, and has recently been repurposed into an extended-release form for the treatment of attention-deficit/hyperactivity disorder in the USA. An immediate-release formulation was approved for the treatment of depression in the UK in 1974, and was subsequently marketed there and in several European countries for 30 years with no major safety concerns. In contrast to first-generation antidepressants (e.

Translating Attention-Deficit/Hyperactivity Disorder Rating Scale-5 and Weiss Functional Impairment Rating Scale-Parent Effectiveness Scores into Clinical Global Impressions Clinical Significance Levels in Four Randomized Clinical Trials of SPN-812 (Viloxazine Extended-Release) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder.

Clinical trials in psychiatry frequently report results from lengthy, comprehensive assessments to characterize a subject emotionally, cognitively, and behaviorally before and after treatment. However, the potential treatment implications of these results and how they translate into clinical practice remain unclear. Conversely, the Clinical Global Impressions (CGI) scales are quick, intuitive assessments used to assess the functional impact of a treatment in clinically relevant terms.

Early response to SPN-812 (viloxazine extended-release) can predict efficacy outcome in pediatric subjects with ADHD: a machine learning post-hoc analysis of four randomized clinical trials.

Machine learning (ML) was used to determine whether early response can predict efficacy outcome in pediatric subjects with ADHD treated with SPN-812. We used data from four Phase 3 placebo-controlled trials of 100- to 600-mg/day SPN-812 (N=1397; 6-17 years of age). The treatment response was defined as having a ≥50% reduction in change from baseline (CFB) in ADHD Rating Scale-5 (ADHD-RS-5) Total score at Week 6.

Current and future nonstimulants in the treatment of pediatric ADHD: monoamine reuptake inhibitors, receptor modulators, and multimodal agents.

Attention-deficit/hyperactivity disorder (ADHD), the single most common neuropsychiatric disorder with cognitive and behavioral manifestations, often starts in childhood and usually persists into adolescence and adulthood. Rarely seen alone, ADHD is most commonly complicated by other neuropsychiatric disorders that must be factored into any intervention plan to optimally address ADHD symptoms. With more than 30 classical Schedule II (CII) stimulant preparations available for ADHD treatment, only three nonstimulants (atomoxetine and extended-release formulations of clonidine and guanfacine) have been approved by the United States Food and Drug Administration (FDA), all of which focus on modulating the noradrenergic system.

Predicted Efficacy of Once-Daily Extended-Release Oxcarbazepine (Oxtellar XR) Monotherapy in Adults and Children with Partial-Onset Seizures: Exposure-Response Modeling and Simulation.

Purpose: We conducted exposure-response modeling and simulations to compare the predicted efficacy of extended-release oxcarbazepine (OXC-XR), an oral once-daily (qd) antiepileptic drug, with that of immediate-release (IR) OXC twice-daily (bid) when the agents are used as monotherapy or adjunctive therapy in patients with epilepsy characterized by partial-onset seizures (POS).

Methods: Modeling assessed percent change from baseline 28-day seizure frequency (PCH) as a function of minimum concentration (C) of monohydroxy derivative (MHD), the clinically relevant metabolite of OXC. For OXC-IR, the model used historical data; values for OXC-XR were derived from observed data.

Closing the gap: unmet needs of individuals with impulsive aggressive behavior observed in children and adolescents.

Impulsive aggressive (IA, or impulsive aggression) behavior describes an aggregate set of maladaptive, aggressive behaviors occurring across multiple neuropsychiatric disorders. IA is reactive, eruptive, sudden, and unplanned; it provides information about the severity, but not the nature, of its associated primary disorder. IA in children and adolescents is of serious clinical concern for patients, families, and physicians, given the detrimental impact pediatric IA can have on development.

Real-world assessment of treatment with extended-release topiramate (Trokendi XR) and comparison with previous immediate-release topiramate treatment.

Aim: Examine clinical profile of extended-release topiramate (Trokendi XR) and compare treatment-emergent adverse events (TEAEs) associated with Trokendi XR versus previous immediate-release topiramate (TPM-IR) treatment.

Patients & Methods: Pilot retrospective study analyzing data extracted from medical charts of patients ≥6 years of age prescribed Trokendi XR.

Results: Trokendi XR was the most commonly used to prevent migraine.

Atrial fibrillation and mortality in African American patients with heart failure: results from the African American Heart Failure Trial (A-HeFT).

Background: Atrial fibrillation (AF) is common in patients with heart failure (HF) and portends a worsened prognosis. Because of the low enrollment of African American subjects (AAs) in randomized HF trials, there are little data on AF in AAs with HF. This post hoc analysis reviews characteristics and outcomes of AA patients with AF in A-HeFT.

A retrospective, observational cohort analysis of a nationwide database to compare heart failure prescriptions and related health care utilization before and after publication of updated treatment guidelines in the United States.

Background: The current American College of Cardiology/American Heart Association (ACC/AHA) clinical guidelines for heart failure (HF), published September 20, 2005, provide a summary of the best evidence for treatment, but these recommendations are not always reflected in clinical practice.

Objectives: The aims of this study were to compare 6-month prescribing habits in the United States before and after the publication of updated clinical guidelines for the evaluation and management of HF and the impact of these prescribing habits on health care resource use.

Methods: This retrospective, observational cohort analysis used the Humana nationwide health insurance administrative claims database that includes -3.

The Metabolic Syndrome in African Americans: a review.

The Metabolic Syndrome represents a specific clustering of cardiovascular risk factors. One of several recently proposed definitions encompasses 3 or more of the following 5 abnormalities: waist circumference > 102 cm in men or > 88 cm in women, serum triglyceride level > or = 150 mg/dL, high-density lipoprotein cholesterol level < 40 mg/dL in men or < 50 mg/dL in women, blood pressure (BP) > or = 130/> or = 85 mm Hg and serum glucose > or = 110 mg/dL. The diagnosis of Metabolic Syndrome allows early recognition of an increased risk of cardiovascular disease.