This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio. One-hundred twenty (120) patients are planned to be randomized. Each patient will receive AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
Florida Clinical Research Center, LLC
Brandenton, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
ADHD-RS-IV
The primary endpoint is the ADHD-RS-IV; change from Baseline to Visit 7 (Day 35).
Time frame: Day 35
CGI-ADHD-S/I
CGI-ADHD-S (severity) and I (improvement) - change from Baseline.
Time frame: Day 35
Conners' Parent Rating Scale
Conners' Parent Rating Scale (CPRS-R-S) will be assessed through Day 49.
Time frame: Day 49
Columbia Suicide Severity Rating Scale (C-SSRS)
Columbia Suicide Severity Rating Scale (C-SSRS) - incident rate will be assessed through Day 49.
Time frame: Day 49
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CNS Healthcare
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Midwest Research Group at St. Charles Psychiatric Associates
Saint Charles, Missouri, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
CNS Healthcare
Memphis, Tennessee, United States
...and 3 more locations