The primary purpose of this study is to evaluate the efficacy of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Oral capsules
Sarkis Clinical Trials - Gainesville
Gainesville, Florida, United States
NOT_YET_RECRUITINGChange From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale Emotional Dysregulation (WRAADDS-ED) Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Clinical Global Impressions-Severity Scale for Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) T-score for the Global Executive Composite (GEC) Scale
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Behavioral Regulation Index (BRI) Scale
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Metacognition Index (MI) Scale
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties in Emotion Regulation Scale (DERS) Total Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Nonacceptance of Emotional Responses (NONACCEPT) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties Engaging in Goal-Directed Behavior (GOALS) DERS Subscale Score
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CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville)
Jacksonville, Florida, United States
NOT_YET_RECRUITINGAccel Research Sites-Maitland
Maitland, Florida, United States
NOT_YET_RECRUITINGNola Research Works
New Orleans, Louisiana, United States
RECRUITINGBoston Clinical Trials
Boston, Massachusetts, United States
NOT_YET_RECRUITINGAdams Clinical - Watertown
Watertown, Massachusetts, United States
NOT_YET_RECRUITINGSt. Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, United States
NOT_YET_RECRUITINGCenter for Psychiatry and Behavioral Medicine. Inc.
Las Vegas, Nevada, United States
NOT_YET_RECRUITINGCenter for Emotional Fitness
Cherry Hill, New Jersey, United States
RECRUITINGThe Medical Research Network, LLC
New York, New York, United States
NOT_YET_RECRUITING...and 6 more locations
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Impulse Control Difficulties (IMPULSE) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Awareness (AWARE) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Limited Access to Emotion Regulation Strategies (STRATEGIES) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Clarity (CLARITY) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Attention-Deficit/Hyperactivity Disorder Symptoms, Executive Function Deficits, and Emotional Dyscontrol as Assessed by the Adult ADHD Self-Report Scale (ASRS) Score
Time frame: Baseline up to Week 8
Number of Participants With Adverse Events
Time frame: Up to Week 9
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Week 9