Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical Trial

Area of Science:

• Psychiatry
• Pharmacology
• Neuroscience

Background:

• Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder affecting adolescents.
• Effective pharmacological interventions are crucial for managing ADHD symptoms and improving quality of life.

Purpose of the Study:

• To evaluate the efficacy, safety, and tolerability of centanafadine, a novel norepinephrine, dopamine, and serotonin reuptake inhibitor.
• To assess centanafadine's effectiveness in treating ADHD in adolescents aged 13-17 years.

Main Methods:

• A randomized, double-blind, placebo-controlled trial involving 459 adolescents diagnosed with ADHD.
• Participants received once-daily centanafadine (164.4 mg or 328.8 mg) or placebo for 6 weeks.
• The primary endpoint was the change in ADHD Rating Scale, version 5 (ADHD-RS-5) total score at week 6.

Main Results:

• Centanafadine 328.8 mg significantly improved ADHD-RS-5 scores compared to placebo (p = .0006), with effects observed as early as week 1.
• The lower dose, centanafadine 164.4 mg, did not meet the primary efficacy endpoint.
• Treatment-emergent adverse events were generally mild to moderate, with decreased appetite, nausea, headache, and rash being most common.

Conclusions:

• Centanafadine at a 328.8 mg dose demonstrated efficacy in treating ADHD in adolescents.
• Both tested doses of centanafadine were generally safe and well-tolerated in the adolescent population.