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

Purpose

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

Conditions

  • ADHD
  • Anxiety
  • Generalized Anxiety
  • Social Anxiety Disorder

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
  • Other: Placebo
    Placebo
Experimental
Centanafadine QD XR fixed dose 328.8mg
  • Drug: Centanafadine
    Centanafadine QD XR fixed dose 328.8mg

Recruiting Locations

Clinical Research Site #017 - Harmonex Neuroscience Research
Dothan 4059102, Alabama 4829764 36303
Contact:
Otsuka Call Center

Clinical Research Center #033 - Woodland International Research Group
Little Rock 4119403, Arkansas 4099753 72211
Contact:
Otsuka call center

Clinical Research Center #048 - Woodland Research Northwest
Rogers 4128894, Arkansas 4099753 72758
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site #052 - Leading Edge Research LA, LLC
Encino 5346649, California 5332921 91316
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Center #008 - Long Beach Clinical Trial Services Inc.
Long Beach 5367929, California 5332921 90806
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site #008 - Long Beach Clinical Trial Services Inc.
Long Beach 5367929, California 5332921 90806
Contact:
Otsuka call center

Clinical Research Site #011 - NRC Research Institute
Orange 5379513, California 5332921 92868
Contact:
Otsuka Call Center

Clinical Research Center #042 - Anderson Clinical Research
Redlands 5386754, California 5332921 92374
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site #037 - Cenexel CIT IE (Clinical Innovations Inc)
Riverside 5387877, California 5332921 92506
Contact:
Otsuka call center

Clinical Research Site #039 - California Neuroscience Research, LLC
Sherman Oaks 5395244, California 5332921 91403
Contact:
Otsuka Call Center

Clinical Research Site #038 - Sunwise Clinical Research
Walnut Creek 5406990, California 5332921 94596
Contact:
Otsuka call center

Clinical Research Site #030 - MCB Clinical Research Centers
Colorado Springs 5417598, Colorado 5417618 80910
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site #045 - Research Center for Clinical Studies
Norwalk 4839822, Connecticut 4831725 06851-4903
Contact:
Otsuka Call Center

Clinical Research Center #035 - Sarkis Clinical Trials
Gainesville 4156404, Florida 4155751 32607-2053
Contact:
Otsuka call center

Clinical Research Site #005 - Clinical Neuroscience Solutions, Inc.
Jacksonville 4160021, Florida 4155751 32256
Contact:
Otsuka Call Center

Clinical Research Site #046 - ARSN-Largo CRU
Largo 4161580, Florida 4155751 33777
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site #010 - Meridien Research/Accel Clinical
Maitland 4163220, Florida 4155751 32751
Contact:
Otsuka call center

Clinical Research Site #015 - Medical Research Group of Central Florida
Orange City 4167055, Florida 4155751 32763
Contact:
Otsuka call center

Clinical Research Site #006 - CNS Healthcare Orlando
Orlando 4167147, Florida 4155751 32801
Contact:
Otsuka Call Center

Clinical Research Site #019 - Segal Trials Innovatice Clinical Research, Inc.
Tamarac 4174738, Florida 4155751 33319
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site #004 - CenExel iResearch, LLC
Decatur 4191124, Georgia 4197000 30030
Contact:
Otsuka call center

Clinical Research Site #002 - Psych Atlanta, PC
Marietta 4207783, Georgia 4197000 30060

Clinical Research Center #032 - CenExel iResearch, LLC
Savannah 4221552, Georgia 4197000 31405
Contact:
Otsuka call center

Clinical Research Center #056 - Research Works INC.
New Orleans 4335045, Louisiana 4331987 70125
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site # 027 - Copley Clinical
Boston 4930956, Massachusetts 6254926 02116
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Center #022 - Boston Clinical Trials - Alcanza Clinical Research, LLC
Boston 4930956, Massachusetts 6254926 02132
Contact:
Otsuka call center

Clinical Research Site #025 - Adams Clinical
Watertown 4954611, Massachusetts 6254926 02472
Contact:
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Clinical Research Site #016 - Clinical Research of Southern Nevada, LLC
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Otsuka Call Center

Clinical Research Center #031 - Center for Emotional Fitness
Cherry Hill 4501198, New Jersey 5101760 08002
Contact:
Otsuka call center

Clinical Research Site #026 - Neurobehavioral Research Inc
Cedarhurst 5111974, New York 5128638 11516
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site #021 - The Medical Research Network, LLC
New York 5128581, New York 5128638 10128
Contact:
Otsuka Call Center

Clinical Research Site #028 - Patient Priority Clinical Sites LLC
Cincinnati 4508722, Ohio 5165418 45215
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site #047 - Insight Clinical Trials
Independence 5158404, Ohio 5165418 44131

Clinical Research Site #009 - Paradigm Research Professionals LLC
Oklahoma City 4544349, Oklahoma 4544379 73116
Contact:
Otsuka call center

Clinical Research Site #023 - Summit Headlands LLC
Portland 5746545, Oregon 5744337 97210
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site # 029 - Lehigh Center for Clinical Research
Allentown 5178127, Pennsylvania 6254927 18103
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Site #014 - Suburban Research Associates
Media 4559575, Pennsylvania 6254927 19063
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Center #059 - Adams Clinical Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
Otsuka-professionalservices@otsuka-us.com

Clinical Research Center #034 - Coastal Carolina Research Center
North Charleston 4589387, South Carolina 4597040 29405
Contact:
Otsuka call center

Clinical Research Site #001 - CNS Healthcare - Memphis
Memphis 4641239, Tennessee 4662168 38119
Contact:
Otsuka Call Center

Clinical Research Site #013 - Donald J. Garcia, Jr. MD., PA
Austin 4671654, Texas 4736286 78737
Contact:
Otsuka call center

Clinical Research Site #020 - Houston Clinical Trials LLC
Bellaire 4673353, Texas 4736286 77401
Contact:
Otsuka Contact Center Otsuka Call Center
844-687-8522
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Clinical Research Site #003 - FutureSearch Trials of Dallas LP
Dallas 4684888, Texas 4736286 75251
Contact:
Otsuka call center

Clinical Research Site #012 - Clinical Trials of Texas
San Antonio 4726206, Texas 4736286 78229
Contact:
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Clinical Research Site #036 - Grayline Research Center
Wichita Falls 4741752, Texas 4736286 76309
Contact:
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Clinical Research Site #024 - Core Clinical Research
Everett 5793933, Washington 5815135 98201
Contact:
Otsuka Contact Center Otsuka Call Center
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Otsuka-professionalservices@otsuka-us.com

Clinical Research Center #062 - Research Works - San Juan
Guaynabo 4565119, PR, Puerto Rico 00966
Contact:
Otsuka Contact Center Otsuka Call Center
8446878522
Otsuka-professionalservices@otsuka-us.com

More Details

NCT ID
NCT06973577
Status
Recruiting
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact

Otsuka Call Center
8446878522
OtsukaUS@druginfo.com

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