NCT06973577

P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety

A Phase 3b, Randomized, Double-blind, 8-week, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Centanafadine Once Daily Extended-release Capsules for the Treatment of Adults With Attention-deficit/Hyperactivity Disorder and Comorbid Anxiety

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Primary: To evaluate the efficacy of CTN in adults ages with ADHD and comorbid anxiety (AISRS) Key Secondary: To assess the efficacy of CTN in adults ages with ADHD and comorbid anxiety

Conditions

• ADHD
• Anxiety
• Generalized Anxiety
• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Centanafadine	Centanafadine QD XR fixed dose 328.8mg
OTHER	Placebo	Placebo

Timeline

• Start date: 2025-03-26
• Primary completion: 2026-04-22
• Completion: 2026-04-29
• First posted: 2025-05-15
• Last updated: 2026-04-07

Locations

47 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study