RecruitingPhase 3NCT06973577

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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Enrollment

308 participants

Start Date

Mar 26, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety Social Anxiety Disorder ADHD Generalized Anxiety

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new medication called CTN in adults who have both ADHD and an anxiety disorder (generalized anxiety or social anxiety), two conditions that commonly occur together and are difficult to treat at the same time. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with ADHD according to DSM-5 criteria - You also have a diagnosis of generalized anxiety disorder (GAD) or social anxiety disorder (SAD) - Your ADHD and anxiety symptoms are both moderate to severe based on standard rating scales - Your BMI is between 18 and 40 **You may NOT be eligible if...** - You have tried and failed two or more types of ADHD or anxiety treatments (of different classes) without benefit - You are currently taking prohibited psychiatric medications that cannot be stopped before the trial - You recently started a new type of therapy (within the past 3 months) - Another psychiatric condition is the main focus of your treatment - You have significant heart conditions or a history of substance abuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCentanafadine

Centanafadine QD XR fixed dose 328.8mg

OTHERPlacebo

Placebo

Locations(47)

Clinical Research Site #017 - Harmonex Neuroscience Research

Dothan, Alabama, United States

Clinical Research Center #033 - Woodland International Research Group

Little Rock, Arkansas, United States

Clinical Research Center #048 - Woodland Research Northwest

Rogers, Arkansas, United States

Clinical Research Site #052 - Leading Edge Research LA, LLC

Encino, California, United States

Clinical Research Center #008 - Long Beach Clinical Trial Services Inc.

Long Beach, California, United States

Clinical Research Site #008 - Long Beach Clinical Trial Services Inc.

Long Beach, California, United States

Clinical Research Site #011 - NRC Research Institute

Orange, California, United States

Clinical Research Center #042 - Anderson Clinical Research

Redlands, California, United States

Clinical Research Site #037 - Cenexel CIT IE (Clinical Innovations Inc)

Riverside, California, United States

Clinical Research Site #039 - California Neuroscience Research, LLC

Sherman Oaks, California, United States

Clinical Research Site #038 - Sunwise Clinical Research

Walnut Creek, California, United States

Clinical Research Site #030 - MCB Clinical Research Centers

Colorado Springs, Colorado, United States

Clinical Research Site #045 - Research Center for Clinical Studies

Norwalk, Connecticut, United States

Clinical Research Center #035 - Sarkis Clinical Trials

Gainesville, Florida, United States

Clinical Research Site #005 - Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Clinical Research Site #046 - ARSN-Largo CRU

Largo, Florida, United States

Clinical Research Site #010 - Meridien Research/Accel Clinical

Maitland, Florida, United States

Clinical Research Site #015 - Medical Research Group of Central Florida

Orange City, Florida, United States

Clinical Research Site #006 - CNS Healthcare Orlando

Orlando, Florida, United States

Clinical Research Site #019 - Segal Trials Innovatice Clinical Research, Inc.

Tamarac, Florida, United States

Clinical Research Site #004 - CenExel iResearch, LLC

Decatur, Georgia, United States

Clinical Research Site #002 - Psych Atlanta, PC

Marietta, Georgia, United States

Clinical Research Center #032 - CenExel iResearch, LLC

Savannah, Georgia, United States

Clinical Research Center #056 - Research Works INC.

New Orleans, Louisiana, United States

Clinical Research Site # 027 - Copley Clinical

Boston, Massachusetts, United States

Clinical Research Center #022 - Boston Clinical Trials - Alcanza Clinical Research, LLC

Boston, Massachusetts, United States

Clinical Research Site #025 - Adams Clinical

Watertown, Massachusetts, United States

Clinical Research Site #016 - Clinical Research of Southern Nevada, LLC

Las Vegas, Nevada, United States

Clinical Research Center #031 - Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Clinical Research Site #026 - Neurobehavioral Research Inc

Cedarhurst, New York, United States

Clinical Research Site #021 - The Medical Research Network, LLC

New York, New York, United States

Clinical Research Site #028 - Patient Priority Clinical Sites LLC

Cincinnati, Ohio, United States

Clinical Research Site #047 - Insight Clinical Trials

Independence, Ohio, United States

Clinical Research Site #009 - Paradigm Research Professionals LLC

Oklahoma City, Oklahoma, United States

Clinical Research Site #023 - Summit Headlands LLC

Portland, Oregon, United States

Clinical Research Site # 029 - Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Clinical Research Site #014 - Suburban Research Associates

Media, Pennsylvania, United States

Clinical Research Center #059 - Adams Clinical Philadelphia

Philadelphia, Pennsylvania, United States

Clinical Research Center #034 - Coastal Carolina Research Center

North Charleston, South Carolina, United States

Clinical Research Site #001 - CNS Healthcare - Memphis

Memphis, Tennessee, United States

Clinical Research Site #013 - Donald J. Garcia, Jr. MD., PA

Austin, Texas, United States

Clinical Research Site #020 - Houston Clinical Trials LLC

Bellaire, Texas, United States

Clinical Research Site #003 - FutureSearch Trials of Dallas LP

Dallas, Texas, United States

Clinical Research Site #012 - Clinical Trials of Texas

San Antonio, Texas, United States

Clinical Research Site #036 - Grayline Research Center

Wichita Falls, Texas, United States

Clinical Research Site #024 - Core Clinical Research

Everett, Washington, United States

Clinical Research Center #062 - Research Works - San Juan

Guaynabo, PR, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT06973577

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