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

NCT06973577 | Completed Phase 3 FDA Drug

• 1 other identifier: 405-201-00180
• Study Type: interventional
• Target: 315
• Locations: 2 countries
• Sites: 47

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Adult Investigator Symptom Rating Scale (AISRS)

  The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement.

  Baseline to Week 8

Secondary Outcomes (1)

• Change in Hamilton Anxiety Rating Scale (HAM-A)

  Baseline to Week 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Centanafadine QD XR fixed dose 328.8mg

EXPERIMENTAL

Drug: Centanafadine

Interventions

Centanafadine DRUG

Centanafadine QD XR fixed dose 328.8mg

Centanafadine QD XR fixed dose 328.8mg

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants between 18 and 65 years of age, inclusive.
• Diagnosis of ADHD per the DSM-5-TR criteria and confirmed using the ACDS Version 1.2 at screening.
• AISRS total score of ≥ 28 at baseline.
• Diagnosis of GAD and/or SAD per DSM-5-TR criteria and confirmed using the MINI at screening.
• HAM-A total score ≥ 20 at baseline.
• CGI-S-ADHD and CGI-S-anxiety rating ≥ 4 at baseline.
• Body mass index from 18.0 to 40.0 kg/m2 (inclusive).
• Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.

You may not qualify if:

• In the clinical opinion of the investigator, participant has not derived therapeutic benefit from 2 or more ADHD therapies of 2 different classes (eg, amphetamine and methylphenidate, or amphetamine and atomoxetine) given with an acceptable dose and duration during adulthood (aged 18 years or older).
• In the clinical opinion of the investigator, participant has not derived therapeutic benefit from 2 or more anxiety therapies of 2 different classes (eg, selegiline and duloxetine, or buspirone and lorazepam) given with an acceptable dose and duration during adulthood (aged 18 years or older).
• Current use of prohibited psychotropic medications that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 28 days of randomization.
• Participants who have started individual or group psychotherapy within the past 3 months prior to screening (ongoing psychotherapy that is not expected to change in frequency or type during the trial is permissible).
• Any disorder that is the primary focus of treatment other than ADHD.
• Participants with lifetime DSM-5-TR diagnosis of neurocognitive disorder, schizophrenia or any psychotic disorder, bipolar disorder, autism spectrum disorder, or personality disorders. Participants with current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, any substance use disorder, eating disorders, major depressive disorder; or other anxiety disorders such as panic disorder, agoraphobia, separation anxiety disorder, selective mutism, substance or medication induced anxiety, or due to medical condition, or specific phobia will be excluded.
• Participant is, in the investigator's judgment, at significant risk for suicide. A participant with a Columbia-Suicide Severity Rating Scale (C-SSRS) ideation score of 4 or 5 within the last 6 months or participants who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) within the past year must be excluded.
• Participants with a positive UDS for illicit drugs at screening or baseline. Participants with a positive drug test at screening for ADHD or anxiety medications including methylphenidate, or amphetamines, may continue while undergoing the required washout. Participants with a positive drug test at baseline for ADHD or anxiety medications are excluded. A positive drug test at baseline for drugs of abuse, including cannabis, unless all of the following cannabis specific conditions are met:
• No DSM-5-TR diagnosis of cannabis use disorder within the past 12 months;
• If per investigator's judgement, cannabis use will not compromise safety, efficacy assessments or protocol compliance.
• Participant agrees to maintain their consistent use pattern throughout the trial
• Participant agrees to refrain from cannabis use within 12 hours of trial visits.
• Participants with evidence of current substance use disorder or history in the past 12 months.
• Participants with epilepsy, a history of epilepsy, or a history of seizure, except for a single childhood febrile seizure, a single seizure post brain injury, or a single seizure due to alcohol withdrawal.
• Participants who are partially hospitalized or receiving inpatient care or have any other medical or physical condition(s) that, in the opinion of the investigator, may prevent the participant from completing the trial or would go against the participant's best interest with participation in the trial. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. This would also include most bariatric surgeries, with the only exception being those where there has been no breach of the gastrointestinal wall (ie, uncomplicated lap band surgery) AND no sign of malabsorption.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (47)

Clinical Research Site #017 - Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

Location

Clinical Research Center #033 - Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Clinical Research Center #048 - Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

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

Encino, California, 91316, United States

Location

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

Long Beach, California, 90806, United States

Location

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

Long Beach, California, 90806, United States

Location

Clinical Research Site #011 - NRC Research Institute

Orange, California, 92868, United States

Location

Clinical Research Center #042 - Anderson Clinical Research

Redlands, California, 92374, United States

Location

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

Riverside, California, 92506, United States

Location

Clinical Research Site #039 - California Neuroscience Research, LLC

Sherman Oaks, California, 91403, United States

Location

Clinical Research Site #038 - Sunwise Clinical Research

Walnut Creek, California, 94596, United States

Location

Clinical Research Site #030 - MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

Location

Clinical Research Site #045 - Research Center for Clinical Studies

Norwalk, Connecticut, 06851-4903, United States

Location

Clinical Research Center #035 - Sarkis Clinical Trials

Gainesville, Florida, 32607-2053, United States

Location

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

Jacksonville, Florida, 32256, United States

Location

Clinical Research Site #046 - ARSN-Largo CRU

Largo, Florida, 33777, United States

Location

Clinical Research Site #010 - Meridien Research/Accel Clinical

Maitland, Florida, 32751, United States

Location

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

Orange City, Florida, 32763, United States

Location

Clinical Research Site #006 - CNS Healthcare Orlando

Orlando, Florida, 32801, United States

Location

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

Tamarac, Florida, 33319, United States

Location

Clinical Research Site #004 - CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

Location

Clinical Research Site #002 - Psych Atlanta, PC

Marietta, Georgia, 30060, United States

Location

Clinical Research Center #032 - CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

Clinical Research Center #056 - Research Works INC.

New Orleans, Louisiana, 70125, United States

Location

Clinical Research Site # 027 - Copley Clinical

Boston, Massachusetts, 02116, United States

Location

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

Boston, Massachusetts, 02132, United States

Location

Clinical Research Site #025 - Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

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

Las Vegas, Nevada, 89128, United States

Location

Clinical Research Center #031 - Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Clinical Research Site #026 - Neurobehavioral Research Inc

Cedarhurst, New York, 11516, United States

Location

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

New York, New York, 10128, United States

Location

Clinical Research Site #028 - Patient Priority Clinical Sites LLC

Cincinnati, Ohio, 45215, United States

Location

Clinical Research Site #047 - Insight Clinical Trials

Independence, Ohio, 44131, United States

Location

Clinical Research Site #009 - Paradigm Research Professionals LLC

Oklahoma City, Oklahoma, 73116, United States

Location

Clinical Research Site #023 - Summit Headlands LLC

Portland, Oregon, 97210, United States

Location

Clinical Research Site # 029 - Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18103, United States

Location

Clinical Research Site #014 - Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Clinical Research Center #059 - Adams Clinical Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research Center #034 - Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Clinical Research Site #001 - CNS Healthcare - Memphis

Memphis, Tennessee, 38119, United States

Location

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

Austin, Texas, 78737, United States

Location

Clinical Research Site #020 - Houston Clinical Trials LLC

Bellaire, Texas, 77401, United States

Location

Clinical Research Site #003 - FutureSearch Trials of Dallas LP

Dallas, Texas, 75251, United States

Location

Clinical Research Site #012 - Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Clinical Research Site #036 - Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Clinical Research Site #024 - Core Clinical Research

Everett, Washington, 98201, United States

Location

Clinical Research Center #062 - Research Works - San Juan

Guaynabo, PR, 00966, Puerto Rico

Location

Related Links

• Otsuka Clinical Trial Website
• Otsuka Clinical Trial Transparency

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Anxiety Disorders; Generalized Anxiety Disorder; Phobia, Social

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Phobic Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: March 26, 2025
• Primary Completion: April 22, 2026
• Study Completion: April 29, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: http://vivli.org/ourmember/Otsuka/

Locations

US (46); PR (1)