Status:
COMPLETED
A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
13-17 years
Phase:
PHASE3
Brief Summary
This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-de...
Detailed Description
The trial consisted of a screening period of up to 28 days (4 weeks), a 42-day (6-week) double-blind treatment period, and a 7 (+ 2)-day follow-up period.
Eligibility Criteria
Inclusion
- Males and females aged 13 to 17 years (inclusive) at the time of informed consent/assent.
- A primary diagnosis of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis criteria as confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- A minimum symptoms total raw score of ≥ 28 on the Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) at baseline for all participants.
- A score of 4 or higher on the Clinical Global Impression - Severity - Attention Deficit/Hyperactivity Disorder (CGI-S-ADHD) at baseline.
Exclusion
- A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Binge Eating Disorder, Anorexia, Bulimia, Oppositional Defiant Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or major depressive disorder (MDD) with current major depressive episode.
- Participants who are breast-feeding and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
- A significant risk of committing suicide based on history and the investigator's clinical judgment, or routine psychiatric status examination, Current suicidal behavior, Imminent risk of injury to self, Active suicidal ideation. History of suicidal behavior (over the last 6 months).
- Body mass index (BMI) ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on United States (US) Centers for Disease Control and Prevention (CDC) criteria.
- Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or is anticipated to start new treatment during the trial.
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2023
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT05257265
Start Date
February 2 2022
End Date
October 5 2023
Last Update
September 27 2024
Active Locations (1)
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1
For additional information regarding sites, contact 844-687-8522
New York, New York, United States, 10012