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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified April 2026 by Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information Provided by (Responsible Party)
Otsuka Pharmaceutical Development & Commercialization, Inc.
Clinicaltrials.gov Identifier
NCT06973577
Other Study ID Numbers:
405-201-00180
First Submitted
May 6, 2025
First Posted
May 14, 2025
Last Update Posted
May 5, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
ADHDAnxietyGeneralized AnxietySocial Anxiety Disorder
Other: PlaceboDrug: Centanafadine

Study Design

Study TypeInterventional
Actual Enrollment315 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleA 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
Study Start DateMarch 25, 2025
Actual Primary Completion DateApril 21, 2026
Actual Study Completion DateApril 28, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
Placebo
Other: Placebo
Placebo
Centanafadine QD XR fixed dose 328.8mg
Drug: Centanafadine
Centanafadine QD XR fixed dose 328.8mg

Outcome Measures

Primary Outcome Measures
  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.
Secondary Outcome Measures
  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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsOtsuka Pharmaceutical Development & Commercialization, Inc.
Locations
Clinical Research Site #017 - Harmonex Neuroscience Research | Dothan Alabama, United States, 36303Clinical Research Center #033 - Woodland International Research Group | Little Rock Arkansas, United States, 72211Clinical Research Center #048 - Woodland Research Northwest | Rogers Arkansas, United States, 72758Clinical Research Site #052 - Leading Edge Research LA, LLC | Encino California, United States, 91316Clinical Research Center #008 - Long Beach Clinical Trial Services Inc. | Long Beach California, United States, 90806Clinical Research Site #008 - Long Beach Clinical Trial Services Inc. | Long Beach California, United States, 90806Clinical Research Site #011 - NRC Research Institute | Orange California, United States, 92868Clinical Research Center #042 - Anderson Clinical Research | Redlands California, United States, 92374Clinical Research Site #037 - Cenexel CIT IE (Clinical Innovations Inc) | Riverside California, United States, 92506Clinical Research Site #039 - California Neuroscience Research, LLC | Sherman Oaks California, United States, 91403Clinical Research Site #038 - Sunwise Clinical Research | Walnut Creek California, United States, 94596Clinical Research Site #030 - MCB Clinical Research Centers | Colorado Springs Colorado, United States, 80910Clinical Research Site #045 - Research Center for Clinical Studies | Norwalk Connecticut, United States, 06851-4903Clinical Research Center #035 - Sarkis Clinical Trials | Gainesville Florida, United States, 32607-2053Clinical Research Site #005 - Clinical Neuroscience Solutions, Inc. | Jacksonville Florida, United States, 32256Clinical Research Site #046 - ARSN-Largo CRU | Largo Florida, United States, 33777Clinical Research Site #010 - Meridien Research/Accel Clinical | Maitland Florida, United States, 32751Clinical Research Site #015 - Medical Research Group of Central Florida | Orange City Florida, United States, 32763Clinical Research Site #006 - CNS Healthcare Orlando | Orlando Florida, United States, 32801Clinical Research Site #019 - Segal Trials Innovatice Clinical Research, Inc. | Tamarac Florida, United States, 33319Clinical Research Site #004 - CenExel iResearch, LLC | Decatur Georgia, United States, 30030Clinical Research Site #002 - Psych Atlanta, PC | Marietta Georgia, United States, 30060Clinical Research Center #032 - CenExel iResearch, LLC | Savannah Georgia, United States, 31405Clinical Research Center #056 - Research Works INC. | New Orleans Louisiana, United States, 70125Clinical Research Site # 027 - Copley Clinical | Boston Massachusetts, United States, 02116Clinical Research Center #022 - Boston Clinical Trials - Alcanza Clinical Research, LLC | Boston Massachusetts, United States, 02132Clinical Research Site #025 - Adams Clinical | Watertown Massachusetts, United States, 02472Clinical Research Site #016 - Clinical Research of Southern Nevada, LLC | Las Vegas Nevada, United States, 89128Clinical Research Center #031 - Center for Emotional Fitness | Cherry Hill New Jersey, United States, 08002Clinical Research Site #026 - Neurobehavioral Research Inc | Cedarhurst New York, United States, 11516Clinical Research Site #021 - The Medical Research Network, LLC | New York New York, United States, 10128Clinical Research Site #028 - Patient Priority Clinical Sites LLC | Cincinnati Ohio, United States, 45215Clinical Research Site #047 - Insight Clinical Trials | Independence Ohio, United States, 44131Clinical Research Site #009 - Paradigm Research Professionals LLC | Oklahoma City Oklahoma, United States, 73116Clinical Research Site #023 - Summit Headlands LLC | Portland Oregon, United States, 97210Clinical Research Site # 029 - Lehigh Center for Clinical Research | Allentown Pennsylvania, United States, 18103Clinical Research Site #014 - Suburban Research Associates | Media Pennsylvania, United States, 19063Clinical Research Center #059 - Adams Clinical Philadelphia | Philadelphia Pennsylvania, United States, 19104Clinical Research Center #034 - Coastal Carolina Research Center | North Charleston South Carolina, United States, 29405Clinical Research Site #001 - CNS Healthcare - Memphis | Memphis Tennessee, United States, 38119Clinical Research Site #013 - Donald J. Garcia, Jr. MD., PA | Austin Texas, United States, 78737Clinical Research Site #020 - Houston Clinical Trials LLC | Bellaire Texas, United States, 77401Clinical Research Site #003 - FutureSearch Trials of Dallas LP | Dallas Texas, United States, 75251Clinical Research Site #012 - Clinical Trials of Texas | San Antonio Texas, United States, 78229Clinical Research Site #036 - Grayline Research Center | Wichita Falls Texas, United States, 76309Clinical Research Site #024 - Core Clinical Research | Everett Washington, United States, 98201Clinical Research Center #062 - Research Works - San Juan | Guaynabo PR, Puerto Rico, 00966