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ADHDPhase 3NCT06973577

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

A Phase 3 study testing Centanafadine in people with ADHD and Anxiety, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 47 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
ADHD, Anxiety, Generalized Anxiety
What is being tested?
Centanafadine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
315 participants
Where
47 sitesin 2 countries
Study dates
26 Mar 2025to 29 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 32Show fewer
  • 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.
  • The following laboratory test and ECG results are exclusionary at screening:
  • Platelets ≤ 75,000/mm3
  • Hemoglobin ≤ 9 g/dL
  • Neutrophils, absolute ≤ 1000/mm3
  • AST > 2 × upper limit of normal
  • ALT > 2 × upper limit of normal
  • Creatinine ≥ 2 mg/dL
  • HbA1c ≥ 7%
  • QTcF ≥ 450 msec for males or ≥ 470 msec for females
  • Abnormal free thyroxin (T4), unless discussed with and approved by the medical monitor (Note: free T4 is measured only if result for thyroid stimulating hormone [TSH] is abnormal)
  • Participants presenting with, or having a history of, uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) or symptomatic hypotension, or orthostatic hypotension which is defined as a decrease of ≥ 30 mmHg in systolic blood pressure or a decrease of ≥ 20 mmHg in diastolic blood pressure after at least 3 minutes standing compared with the previous supine blood pressure, or development of symptoms.
  • Participants with a history of any prior exposure to centanafadine.
  • Participants who have participated in other clinical trials involving investigational drugs within 180 days prior to screening or who have participated in more than 2 interventional clinical trials involving investigational drugs within the past year.
  • Participants of childbearing potential who are breast-feeding and/or have a positive pregnancy test result prior to receiving IMP.
  • Participants of reproductive potential / POCBP who do not agree to practice 2 different effective and/or highly effective methods of birth control or remain fully abstinent from sexual activity with the potential for conception, per the guidelines in Section 10.3.
  • Participants who do not agree to refrain from donating sperm or eggs from trial screening through 90 days for sperm and 30 days for eggs after the last dose of IMP.
  • Participants who have an allergy to the IMP or any component of the IMP.

Trial locations and contacts

47 sites in 2 countries.

47 sites in 2 countries

United States46 sites

  • Clinical Research Site # 029 - Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18103

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

    Austin, Texas, 78737

  • Clinical Research Site #020 - Houston Clinical Trials LLC

    Bellaire, Texas, 77401

  • Clinical Research Site # 027 - Copley Clinical

    Boston, Massachusetts, 02116

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

    Boston, Massachusetts, 02132

  • Clinical Research Site #026 - Neurobehavioral Research Inc

    Cedarhurst, New York, 11516

  • Clinical Research Center #031 - Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Clinical Research Site #028 - Patient Priority Clinical Sites LLC

    Cincinnati, Ohio, 45215

  • Clinical Research Site #030 - MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910

  • Clinical Research Site #003 - FutureSearch Trials of Dallas LP

    Dallas, Texas, 75251

  • Clinical Research Site #004 - CenExel iResearch, LLC

    Decatur, Georgia, 30030

  • Clinical Research Site #017 - Harmonex Neuroscience Research

    Dothan, Alabama, 36303

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

    Encino, California, 91316

  • Clinical Research Site #024 - Core Clinical Research

    Everett, Washington, 98201

  • Clinical Research Center #035 - Sarkis Clinical Trials

    Gainesville, Florida, 32607-2053

  • Clinical Research Site #047 - Insight Clinical Trials

    Independence, Ohio, 44131

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

    Jacksonville, Florida, 32256

  • Clinical Research Site #046 - ARSN-Largo CRU

    Largo, Florida, 33777

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

    Las Vegas, Nevada, 89128

  • Clinical Research Center #033 - Woodland International Research Group

    Little Rock, Arkansas, 72211

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

    Long Beach, California, 90806

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

    Long Beach, California, 90806

  • Clinical Research Site #010 - Meridien Research/Accel Clinical

    Maitland, Florida, 32751

  • Clinical Research Site #002 - Psych Atlanta, PC

    Marietta, Georgia, 30060

  • Clinical Research Site #014 - Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical Research Site #001 - CNS Healthcare - Memphis

    Memphis, Tennessee, 38119

  • Clinical Research Center #056 - Research Works INC.

    New Orleans, Louisiana, 70125

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

    New York, New York, 10128

  • Clinical Research Center #034 - Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Clinical Research Site #045 - Research Center for Clinical Studies

    Norwalk, Connecticut, 06851-4903

  • Clinical Research Site #009 - Paradigm Research Professionals LLC

    Oklahoma City, Oklahoma, 73116

  • Clinical Research Site #011 - NRC Research Institute

    Orange, California, 92868

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

    Orange City, Florida, 32763

  • Clinical Research Site #006 - CNS Healthcare Orlando

    Orlando, Florida, 32801

  • Clinical Research Center #059 - Adams Clinical Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Clinical Research Site #023 - Summit Headlands LLC

    Portland, Oregon, 97210

  • Clinical Research Center #042 - Anderson Clinical Research

    Redlands, California, 92374

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

    Riverside, California, 92506

  • Clinical Research Center #048 - Woodland Research Northwest

    Rogers, Arkansas, 72758

  • Clinical Research Site #012 - Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Clinical Research Center #032 - CenExel iResearch, LLC

    Savannah, Georgia, 31405

  • Clinical Research Site #039 - California Neuroscience Research, LLC

    Sherman Oaks, California, 91403

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

    Tamarac, Florida, 33319

  • Clinical Research Site #038 - Sunwise Clinical Research

    Walnut Creek, California, 94596

  • Clinical Research Site #025 - Adams Clinical

    Watertown, Massachusetts, 02472

  • Clinical Research Site #036 - Grayline Research Center

    Wichita Falls, Texas, 76309

Other trials in United States

Puerto Rico1 site

  • Clinical Research Center #062 - Research Works - San Juan

    Guaynabo, PR, 00966

Other trials in Puerto Rico

About this study

Official title: 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

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

Being tested
Centanafadine, Placebo
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Anxiety Disorders, Generalized Anxiety Disorder, Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CentanafadineDrug

    Centanafadine QD XR fixed dose 328.8mg

  • PlaceboOther

    Placebo

Study groups in NCT06973577
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo
Centanafadine QD XR fixed dose 328.8mgExperimentalNot described
Receives: Drug: Centanafadine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 8

Secondary outcomes (1)

  1. Change in Hamilton Anxiety Rating Scale (HAM-A)

    The HAM-A consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a 5-point scale, ranging from 0 = not present to 4 = very severe. Negative change from Baseline indicates improvement.

    Measured: Baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2025
  2. Study start26 Mar 2025
  3. Primary completion22 Apr 2026
  4. Study completion29 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06973577
Sponsor's protocol ID
405-201-00180
Status last verified
May 2026
First submitted
7 May 2025
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized Individual participant data (IPD) that underlie the result of this study will be shared with researchers to achieve aims pre-specified in a methodology sound research proposal. Supporting Information:

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Centanafadine in people with ADHD and Anxiety, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 47 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Adult Investigator Symptom Rating Scale (AISRS) (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06973577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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