The primary objective of this study is to evaluate the long-term safety and tolerability of methylphenidate hydrochloride extended-release capsules (Aptensio XR®) in children aged 4-5 years who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD). Safety and tolerability will be evaluated by assessing treatment-emergent adverse events (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory The primary objective of this study is to evaluate the long-term (12-month) safety and tolerability of Aptensio XR® in children aged 4 to less than 6 years who have been diagnosed with ADHD. Safety and tolerability will be evaluated by assessing treatment-emergent adverse events (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory values and Columbia Suicide Severity Rating Scale (C-SSRS). Disturbances in sleep (quantity and quality) patterns will also be assessed using the Child Sleep Habits Questionnaire (CSHQ). Secondary objectives include assessment of long-term efficacy of Aptensio XR®. Secondary measures include: * Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale Preschool Version (ADHD-RS-IV Preschool Version) * Clinical Global Impressions-Severity Scale (CGI-S ) * Connors Early Childhood Behavior-Parent Short form \[Conners EC BEH-P(S)\]
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Orally-administered extended release formulation of methylphenidate; once daily dosing
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, United States
Duke University Medical Center
Durham, North Carolina, United States
Treatment-emergent adverse events (TEAEs)
Incidence of TEAEs during maintenance phase
Time frame: 12 month maintenance phase
Columbia Suicide Severity Rating Scale (C-SSRS)
Standardized assessment of suicide risk
Time frame: 12 month maintenance phase
Vital signs
blood pressure, pulse, height, weight
Time frame: 12 month maintenance phase
12-lead electrocardiogram
Time frame: 12 month maintenance phase
ADHD-RS-IV Preschool Version
Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale Preschool Version (ADHD-RS-IV Preschool Version) to assess ADHD severity and functioning
Time frame: 12 month maintenance phase
Clinical Global Impressions-Severity Scale (CGI-S)
This scale provides a global rating of illness severity and improvement during the study. The subject is rated relative to the clinician's past experience with other patients who have the same diagnosis. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients).
Time frame: 12 month maintenance phase
Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)]
Assesses behavior of preschool-aged children 2 to 6
Time frame: 12 month maintenance phase
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