P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety
NCT ID: NCT06973577
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
308 participants
INTERVENTIONAL
2025-03-26
2027-10-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Placebo
Placebo
Placebo
Centanafadine QD XR fixed dose 328.8mg
Centanafadine
Centanafadine QD XR fixed dose 328.8mg
Interventions
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Centanafadine
Centanafadine QD XR fixed dose 328.8mg
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Clinical Research Site #004 - CenExel iResearch, LLC
Decatur, Georgia, United States
Clinical Research Site #002 - Psych Atlanta, PC
Marietta, Georgia, United States
Clinical Research Center #032 - CenExel iResearch, LLC
Savannah, Georgia, United States
Clinical Research Center #056 - Research Works INC.
New Orleans, Louisiana, United States
Clinical Research Site # 027 - Copley Clinical
Boston, Massachusetts, United States
Clinical Research Center #022 - Boston Clinical Trials - Alcanza Clinical Research, LLC
Boston, Massachusetts, United States
Clinical Research Site #025 - Adams Clinical
Watertown, Massachusetts, United States
Clinical Research Site #016 - Clinical Research of Southern Nevada, LLC
Las Vegas, Nevada, United States
Clinical Research Center #031 - Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Clinical Research Site #026 - Neurobehavioral Research Inc
Cedarhurst, New York, United States
Clinical Research Site #021 - The Medical Research Network, LLC
New York, New York, United States
Clinical Research Site #028 - Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States
Clinical Research Site #047 - Insight Clinical Trials
Independence, Ohio, United States
Clinical Research Site #009 - Paradigm Research Professionals LLC
Oklahoma City, Oklahoma, United States
Clinical Research Site #023 - Summit Headlands LLC
Portland, Oregon, United States
Clinical Research Site # 029 - Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Clinical Research Site #014 - Suburban Research Associates
Media, Pennsylvania, United States
Clinical Research Center #059 - Adams Clinical Philadelphia
Philadelphia, Pennsylvania, United States
Clinical Research Center #034 - Coastal Carolina Research Center
North Charleston, South Carolina, United States
Clinical Research Site #001 - CNS Healthcare - Memphis
Memphis, Tennessee, United States
Clinical Research Site #013 - Donald J. Garcia, Jr. MD., PA
Austin, Texas, United States
Clinical Research Site #020 - Houston Clinical Trials LLC
Bellaire, Texas, United States
Clinical Research Site #003 - FutureSearch Trials of Dallas LP
Dallas, Texas, United States
Clinical Research Site #012 - Clinical Trials of Texas
San Antonio, Texas, United States
Clinical Research Site #036 - Grayline Research Center
Wichita Falls, Texas, United States
Clinical Research Site #024 - Core Clinical Research
Everett, Washington, United States
Clinical Research Center #062 - Research Works - San Juan
Guaynabo, PR, Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Otsuka Call Center
Role: primary
Otsuka call center
Role: primary
Otsuka call center
Role: primary
Otsuka Call Center
Role: primary
Otsuka call center
Role: primary
Otsuka Call Center
Role: primary
Otsuka call center
Role: primary
Otsuka Call Center
Role: primary
Otsuka call center
Role: primary
Otsuka Call Center
Role: primary
Otsuka call center
Role: primary
Otsuka call center
Role: primary
Otsuka Call Center
Role: primary
Otsuka call center
Role: primary
Otsuka call center
Role: primary
Otsuka call center
Role: primary
Otsuka call center
Role: primary
Otsuka Call Center
Role: primary
Otsuka call center
Role: primary
Otsuka Call Center
Role: primary
Otsuka call center
Role: primary
Otsuka call center
Role: primary
Otsuka Call Center
Role: primary
Otsuka call center
Role: primary
Otsuka call center
Role: primary
Otsuka Call Center
Role: primary
Otsuka call center
Role: primary
Otsuka call center
Role: backup
Other Identifiers
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405-201-00180
Identifier Type: -
Identifier Source: org_study_id
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