Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety (NCT06973577) is a Phase 3 interventional studying ADHD and Anxiety, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For ADHD, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 308 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants between 18 and 65 years of age, inclusive. 2. Diagnosis of ADHD per the DSM-5-TR criteria and confirmed using the ACDS Version 1.2 at screening. 3. AISRS total score of ≥ 28 at baseline. 4. Diagnosis of GAD and/or SAD per DSM-5-TR criteria and confirmed using the MINI at screening. 5. HAM-A total score ≥ 20 at baseline. 6. CGI-S-ADHD and CGI-S-anxiety rating ≥ 4 at baseline. 7. Body mass index from 18.0 to 40.0 kg/m2 (inclusive). 8. Ability to provide written, willing to sign a consent form 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 Should NOT Join This Trial: 1. 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). 2. 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). 3. Current use of prohibited psychotropic medications that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 28 days of randomization. 4. 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). 5. Any disorder that is the primary focus of treatment other than ADHD. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Participants between 18 and 65 years of age, inclusive. 2. Diagnosis of ADHD per the DSM-5-TR criteria and confirmed using the ACDS Version 1.2 at screening. 3. AISRS total score of ≥ 28 at baseline. 4. Diagnosis of GAD and/or SAD per DSM-5-TR criteria and confirmed using the MINI at screening. 5. HAM-A total score ≥ 20 at baseline. 6. CGI-S-ADHD and CGI-S-anxiety rating ≥ 4 at baseline. 7. Body mass index from 18.0 to 40.0 kg/m2 (inclusive). 8. 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. Exclusion Criteria: 1. 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). 2. 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). 3. Current use of prohibited psychotropic medications that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 28 days of randomization. 4. 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). 5. Any disorder that is the primary focus of treatment other than ADHD. 6. 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. 7. 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. 8. 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: 1. No DSM-5-TR diagnosis of cannabis use disorder within the past 12 months; 2. If per investigator's judgement, cannabis use will not compromise safety, efficacy assessments or protocol compliance. 3. Participant agrees to maintain their consistent use pattern throughout the trial 4. Participant agrees to refrain from cannabis use within 12 hours of trial visits. 9. Participants with evidence of current substance use disorder or history in the past 12 months. 10. 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. 11. 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. 12. The following laboratory test and ECG results are exclusionary at screening: 1. Platelets ≤ 75,000/mm3 2. Hemoglobin ≤ 9 g/dL 3. Neutrophils, absolute ≤ 1000/mm3 4. AST \> 2 × upper limit of normal 5. ALT \> 2 × upper limit of normal 6. Creatinine ≥ 2 mg/dL 7. HbA1c ≥ 7% 8. QTcF ≥ 450 msec for males or ≥ 470 msec for females 9. 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) 13. 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. 14. Participants with a history of any prior exposure to centanafadine. 15. 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. 16. Participants of childbearing potential who are breast-feeding and/or have a positive pregnancy test result prior to receiving IMP. 17. 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. 18. 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. 19. Participants who have an allergy to the IMP or any component of the IMP.

Treatments Being Tested

DRUG

Centanafadine

Centanafadine QD XR fixed dose 328.8mg

OTHER

Placebo

Placebo

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06973577), the sponsor (Otsuka Pharmaceutical Development & Commercialization, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06973577 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06973577?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06973577?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06973577. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06973577. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.