RECRUITING

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

Conditions

ADHD Anxiety Generalized Anxiety Social Anxiety Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2025-03-26

Study Completion:2027-10-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06973577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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

Study Contact

Otsuka Call Center

CONTACT

8446878522

OtsukaUS@druginfo.com

Study Locations (Sites)

Clinical Research Site #017 - Harmonex Neuroscience Research

Dothan, Alabama, 36303

United States

Clinical Research Center #033 - Woodland International Research Group

Little Rock, Arkansas, 72211

United States

Clinical Research Center #048 - Woodland Research Northwest

Rogers, Arkansas, 72758

United States

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

Encino, California, 91316

United States

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

Long Beach, California, 90806

United States

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

Long Beach, California, 90806

United States

Clinical Research Site #011 - NRC Research Institute

Orange, California, 92868

United States

Clinical Research Center #042 - Anderson Clinical Research

Redlands, California, 92374

United States

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

Riverside, California, 92506

United States

Clinical Research Site #039 - California Neuroscience Research, LLC

Sherman Oaks, California, 91403

United States

Clinical Research Site #038 - Sunwise Clinical Research

Walnut Creek, California, 94596

United States

Clinical Research Site #030 - MCB Clinical Research Centers

Colorado Springs, Colorado, 80910

United States

Clinical Research Site #045 - Research Center for Clinical Studies

Norwalk, Connecticut, 06851-4903

United States

Clinical Research Center #035 - Sarkis Clinical Trials

Gainesville, Florida, 32607-2053

United States

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

Jacksonville, Florida, 32256

United States

Clinical Research Site #046 - ARSN-Largo CRU

Largo, Florida, 33777

United States

Clinical Research Site #010 - Meridien Research/Accel Clinical

Maitland, Florida, 32751

United States

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

Orange City, Florida, 32763

United States

Clinical Research Site #006 - CNS Healthcare Orlando

Orlando, Florida, 32801

United States

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

Tamarac, Florida, 33319

United States

Clinical Research Site #004 - CenExel iResearch, LLC

Decatur, Georgia, 30030

United States

Clinical Research Site #002 - Psych Atlanta, PC

Marietta, Georgia, 30060

United States

Clinical Research Center #032 - CenExel iResearch, LLC

Savannah, Georgia, 31405

United States

Clinical Research Center #056 - Research Works INC.

New Orleans, Louisiana, 70125

United States

Clinical Research Site # 027 - Copley Clinical

Boston, Massachusetts, 02116

United States

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

Boston, Massachusetts, 02132

United States

Clinical Research Site #025 - Adams Clinical

Watertown, Massachusetts, 02472

United States

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

Las Vegas, Nevada, 89128

United States

Clinical Research Center #031 - Center for Emotional Fitness

Cherry Hill, New Jersey, 08002

United States

Clinical Research Site #026 - Neurobehavioral Research Inc

Cedarhurst, New York, 11516

United States

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

New York, New York, 10128

United States

Clinical Research Site #028 - Patient Priority Clinical Sites LLC

Cincinnati, Ohio, 45215

United States

Clinical Research Site #047 - Insight Clinical Trials

Independence, Ohio, 44131

United States

Clinical Research Site #009 - Paradigm Research Professionals LLC

Oklahoma City, Oklahoma, 73116

United States

Clinical Research Site #023 - Summit Headlands LLC

Portland, Oregon, 97210

United States

Clinical Research Site # 029 - Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18103

United States

Clinical Research Site #014 - Suburban Research Associates

Media, Pennsylvania, 19063

United States

Clinical Research Center #059 - Adams Clinical Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Clinical Research Center #034 - Coastal Carolina Research Center

North Charleston, South Carolina, 29405

United States

Clinical Research Site #001 - CNS Healthcare - Memphis

Memphis, Tennessee, 38119

United States

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

Austin, Texas, 78737

United States

Clinical Research Site #020 - Houston Clinical Trials LLC

Bellaire, Texas, 77401

United States

Clinical Research Site #003 - FutureSearch Trials of Dallas LP

Dallas, Texas, 75251

United States

Clinical Research Site #012 - Clinical Trials of Texas

San Antonio, Texas, 78229

United States

Clinical Research Site #036 - Grayline Research Center

Wichita Falls, Texas, 76309

United States

Clinical Research Site #024 - Core Clinical Research

Everett, Washington, 98201

United States

Collaborators and Investigators

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-26

Study Completion Date2027-10-04

Study Record Updates

Study Start Date2025-03-26

Study Completion Date2027-10-04

Terms related to this study

Additional Relevant MeSH Terms

ADHD
Anxiety
Generalized Anxiety
Social Anxiety Disorder