A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

Phase 3 Completed 459 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD).

Timeline

Start: 2022-02-02
Primary completion: 2023-09-29
Completion: 2023-10-05

Publications

Ward CL, Childress AC, Jin N, Turkoglu O, Skubiak T, Wilens TE. Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2026 Jun;65(6):805-817. doi: 10.1016/j.jaac.2025.06.023. Epub 2025 Jul 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Centanafadine	Small molecule	164.4 mg	Oral
Subject	Centanafadine	Small molecule	328.8 mg	Oral

A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

Summary

Timeline

Publications

Drugs

Indications