A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.
A multicenter, randomized, double-blind, active- and placebo-controlled, parallel-design trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
239
OPC-64005 film coated tablets
Atomoxetine gelatin capsules
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Change From Baseline in Conners' Adult ADHD Rating Scales-Observer: Screening Version (CAARS-O:SV) 18-item ADHD Symptoms Total Score at Day 56
The investigator-administered CAARS-O:SV consists of 18 items based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). It includes a 9-item inattentive symptom subscale and a 9-item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. The total score is the sum of individual scores and can range from 0 to 54. Higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement.
Time frame: Baseline, Day 56
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Southern California Research, LLC
Beverly Hills, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States
Meridien Research
Bradenton, Florida, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Behavioral Clinical Research, Inc.
North Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
...and 16 more locations