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Evaluating Centanafadine for Adults with ADHD and Anxiety

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

Phase 3 Interventional Otsuka Pharmaceutical Development & Commercialization, Inc. · NCT06973577

This study is testing if a new medication called Centanafadine can help adults with ADHD and anxiety feel better over 8 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment308 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc. Industry-sponsored
Locations8 sites (Dothan, Alabama and 7 other locations)
Trial IDNCT06973577 on ClinicalTrials.gov

What this trial studies

This Phase 3b clinical trial assesses the efficacy and safety of Centanafadine, an extended-release medication, in adults diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD) and comorbid anxiety disorders. The study is randomized, double-blind, and placebo-controlled, lasting 8 weeks, and aims to determine how well Centanafadine can improve symptoms of both ADHD and anxiety. Participants will be monitored for changes in their ADHD and anxiety symptoms using standardized assessment tools throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with a confirmed diagnosis of ADHD and comorbid generalized anxiety disorder or social anxiety disorder.

Not a fit: Patients who have not experienced significant therapeutic benefit from two or more ADHD therapies of different classes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for adults struggling with both ADHD and anxiety, potentially improving their overall quality of life.

How similar studies have performed: Other studies have shown promise in treating ADHD and anxiety with pharmacological interventions, but the specific approach of using Centanafadine in this population is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants between 18 and 65 years of age, inclusive.
2. Diagnosis of ADHD per the DSM-5 criteria and confirmed using the ACDS Version 1.2 at screening.
3. AISRS total score of ≥ 28 at baseline.
4. Diagnosis of GAD or SAD per DSM-5 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 significant 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 opinion of the investigator, participant has not derived significant 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. Subjects 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. Psychosis, bipolar disorder, MDD, post-traumatic stress disorder, dementia, obsessive compulsive disorder, personality disorders, substance/medication induced anxiety, anxiety disorder due to another medical condition, specific phobia if this is the primary reason for treatment, selective mutism.
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 drug test at baseline for ADHD and anxiety medication including methylphenidate, amphetamine, or for drugs of abuse. Participants with a positive drug screen for confirmed prescription or over-the-counter (OTC) use of ADHD and anxiety medications at screening will be required to undergo a washout period.
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.
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 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.

Where this trial is running

Dothan, Alabama and 7 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ADHDAnxiety, Generalized Anxiety, Social Anxiety Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.