Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
Conditions
Keywords
ADHD, ED
Brief summary
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).
Interventions
DRUGCentanafadine XR
Oral capsules
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS). 2. Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline. 3. Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline. 4. CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.
Exclusion criteria
1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a lifetime diagnosis of bipolar and related disorders, schizophrenia spectrum and other psychotic disorders, borderline and antisocial personality disorders, neurocognitive disorders, autism spectrum disorder, or intellectual disability. 2. DSM-5 criteria for a current diagnosis of major depressive disorder, post-traumatic stress disorder, any substance use disorder, untreated/unstable obstructive sleep apnea, eating disorders, or obsessive compulsive disorder. 3. Any other current DSM-5 comorbid psychiatric disorder identified by the Mini International Neuropsychiatric Interview (MINI) or any medical condition that, in the judgment of the investigator, could be expected to require treatment with medications prohibited in this trial that cannot be safely discontinued with completion of an appropriate washout, could confound efficacy or safety assessments, or be the primary driver of ED. 4. Presence of an unstable or uncontrolled medical condition that, in the opinion of the investigator, could pose a safety risk to the participant or could manifest with psychiatric symptoms (eg, thyroid disease). 5. In the clinical opinion of the investigator, the participant has not derived significant 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). 6. Current use of prohibited psychotropic medications that cannot be discontinued within 7 to 28 days prior to enrollment. 7. Any disorder that is the primary focus of treatment other than ADHD. 8. Evidence of current substance use disorder or history in the past 12 months. 9. History of any prior exposure to centanafadine. 10. Participated in other clinical trials involving investigational drugs within 180 days prior to screening or participated in more than 2 interventional clinical trials involving investigational drugs within the past year. 11. Have an allergy to the IMP or any component of the IMP. Note: Other protocol-specified inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score | Baseline up to Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale Emotional Dysregulation (WRAADDS-ED) Subscale Score | 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 | 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 | Baseline up to Week 8 |
| Change From Baseline to Week 8 in the BRIEF-A T-score for the Behavioral Regulation Index (BRI) Scale | Baseline up to Week 8 |
| Change From Baseline to Week 8 in the BRIEF-A T-score for the Metacognition Index (MI) Scale | Baseline up to Week 8 |
| Change From Baseline to Week 8 in the Difficulties in Emotion Regulation Scale (DERS) Total Score | Baseline up to Week 8 |
| Change From Baseline to Week 8 in the Nonacceptance of Emotional Responses (NONACCEPT) DERS Subscale Score | Baseline up to Week 8 |
| Change From Baseline to Week 8 in the Difficulties Engaging in Goal-Directed Behavior (GOALS) DERS Subscale Score | Baseline up to Week 8 |
| Change From Baseline to Week 8 in the Impulse Control Difficulties (IMPULSE) DERS Subscale Score | Baseline up to Week 8 |
| Change From Baseline to Week 8 in the Lack of Emotional Awareness (AWARE) DERS Subscale Score | Baseline up to Week 8 |
| Change From Baseline to Week 8 in the Limited Access to Emotion Regulation Strategies (STRATEGIES) DERS Subscale Score | Baseline up to Week 8 |
| Change From Baseline to Week 8 in the Lack of Emotional Clarity (CLARITY) DERS Subscale Score | 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 | Baseline up to Week 8 |
| Number of Participants With Adverse Events | Up to Week 9 |
| Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Week 9 |
Countries
United States
Contacts
CONTACTOtsuka Call Center
Outcome results
None listed