The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Clinical Study Center
Little Rock, Arkansas, United States
UCI Child Development Center
Irvine, California, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
Bayou City Research, Ltd.
Houston, Texas, United States
PERMP (Permanent Product Measure of Performance)
Time frame: 0.5 hours pre-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 2 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 4 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 8 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 12 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 14 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 16 hours post-dosing
Time Segment Rating System (ADHD-RS[TSRS])
Time frame: 5½, 11, and 16½ hours post-dosing
Subject self report (ADHD-SRS) of ADHD
Time frame: approximately 5½, 11, and 16½ hours post-dosing
Treatment emergent adverse events
Time frame: Throughout the study period of approximately 3.25 months.
Modified Pittsburgh Sleep Quality Index (PSQI)
Time frame: Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.