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Norepinephrine-Dopamine Reuptake Inhibitor

Double-blind Treatment Period: Centanafadine SR 200 mg for Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 59 days
Awards & highlights

Summary

This study evaluates the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder (ADHD). Participants will either receive a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 59 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 59 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS)
Secondary study objectives
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S)
Other study objectives
ADHD Impact Module - Adult (AIM-A)
Adult ADHD Investigator Symptom Rating Scale (AISRS)
Adult ADHD Self Report Scale (ASRS)
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Single-blind Run-in Period: PlaceboExperimental Treatment1 Intervention
Placebo-matching tablets BID (twice daily) on Day -7 through Baseline (Day -1).
Group II: Double-blind Treatment Period: Centanafadine SR 400 mgExperimental Treatment1 Intervention
Following Single-blind Run-in Period, participants with \<30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine 400 mg SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
Group III: Double-blind Treatment Period: Centanafadine SR 200 mgExperimental Treatment1 Intervention
Following Single-blind Run-in Period, participants with \<30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine 200 mg SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
Group IV: Double-blind Treatment Period: PlaceboPlacebo Group1 Intervention
Following Single-blind Run-in Period, participants with \<30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine SR matching placebo tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Centanafadine SR
2019
Completed Phase 3
~1860

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
264 Previous Clinical Trials
169,476 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
3,873 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
~91 spots leftby Sep 2025
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