Safety and Efficacy of Centanafadine Sustained-Release in Adults With Attention-Deficit Hyperactivity Disorder: Results of Phase 2 Studies
| Autor: | Eva Kohegyi, Timothy E. Wilens, Anthony McKinney, Timothy Wigal, Mary Hobart, Sharon B. Wigal, Jessica J Madera, Ross A. Baker |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
business.industry Nausea Placebo medicine.disease Crossover study Decreased appetite 030227 psychiatry 03 medical and health sciences 0302 clinical medicine Tolerability Internal medicine Centanafadine Medicine Attention deficit hyperactivity disorder medicine.symptom business Adverse effect 030217 neurology & neurosurgery |
| Zdroj: | Neuropsychiatric Disease and Treatment. 16:1411-1426 |
| ISSN: | 1178-2021 |
| DOI: | 10.2147/ndt.s242084 |
| Popis: | Purpose Two phase 2 studies evaluated the efficacy and tolerability of centanafadine sustained-release (SR) for adults with attention-deficit/hyperactivity disorder (ADHD). Patients and Methods In a phase 2a, flexible-dose, single-blind study, 41 male patients (aged 18‒55 years) with a diagnosis of ADHD (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) were titrated with centanafadine-SR 200‒300, 400, or 500 mg/d for 2 weeks, and then were treated with the titrated dose for 2 weeks. In a phase 2b, randomized, double-blind, placebo-controlled, crossover study, 85 male and female patients (aged 18‒60 years) with a diagnosis of ADHD (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) were titrated to target doses of centanafadine-SR 400, 500, 600, or 800 mg/d over the course of 1 week, and then received their titrated dose for 3 weeks. The primary outcome in both studies was mean total ADHD Rating Scale-IV (ADHD-RS-IV) score. Results In the phase 2a study, mean ADHD-RS-IV total score decreased by 21.41 (standard deviation 10.74) from the start of active centanafadine-SR treatment to the end of week 4 (P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|