The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
- Conditions
- Adult Attention Deficit Hyperactivity Disorder
- Interventions
- Registration Number
- NCT03324581
- Brief Summary
A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.
- Detailed Description
A multicenter, randomized, double-blind, active- and placebo-controlled, parallel-design trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 239
Not provided
- Participants with a history of inadequate response or suboptimal tolerability to atomoxetine.
- Participants who report allergies (lifetime treatment history) to stimulant or nonstimulant ADHD medications.
- Participants with other DSM-5 disorders including psychosis (current or lifetime), bipolar disorder (current or lifetime), current major depressive disorder, or current panic disorder; or another psychiatric diagnosis that the investigator believes is primary or that will confound efficacy or safety assessments of the trail or interfere with participation in the trial otherwise.
- Participants with a clinically significant current DSM-5 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, histrionic, narcissistic, avoidant, obsessive compulsive, or dependent personality disorders.
- Participants who currently have clinically significant dermatological, neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV (human immunodeficiency virus) seropositive status/acquired immunodeficiency syndrome, or active or chronic hepatitis B or C.
- Participants with a history of obstructive sleep apnea.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OPC-64005 Placebo During the titration period, participants received OPC-64005 two 10 milligram (mg) tablets, and one OPC-64005-matching placebo tablet along with two atomoxetine-matching placebo capsules, orally, once daily (QD), from Day 1 up to Day 4. During the treatment period, participants received OPC-64005 three 10 mg tablets, and two atomoxetine-matching placebo capsules, orally, QD, from Day 5 up to Day 56. The dose was reduced to 20 mg if the 30 mg dose in the treatment period was not tolerable. Atomoxetine Placebo During the titration period, participants received atomoxetine one 40 mg capsule and one atomoxetine-matching placebo capsule along with three OPC-64005-matching placebo tablets, orally, QD, from Day 1 up to Day 4. During the treatment period, participants received two atomoxetine 40 mg capsules and three OPC-64005-matching placebo tablets, orally, QD, from Day 5 up to Day 56. The dose was reduced to 40 mg if the 80 mg dose in the treatment period was not tolerable. Placebo Placebo Participants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56. OPC-64005 OPC-64005 During the titration period, participants received OPC-64005 two 10 milligram (mg) tablets, and one OPC-64005-matching placebo tablet along with two atomoxetine-matching placebo capsules, orally, once daily (QD), from Day 1 up to Day 4. During the treatment period, participants received OPC-64005 three 10 mg tablets, and two atomoxetine-matching placebo capsules, orally, QD, from Day 5 up to Day 56. The dose was reduced to 20 mg if the 30 mg dose in the treatment period was not tolerable. Atomoxetine Atomoxetine During the titration period, participants received atomoxetine one 40 mg capsule and one atomoxetine-matching placebo capsule along with three OPC-64005-matching placebo tablets, orally, QD, from Day 1 up to Day 4. During the treatment period, participants received two atomoxetine 40 mg capsules and three OPC-64005-matching placebo tablets, orally, QD, from Day 5 up to Day 56. The dose was reduced to 40 mg if the 80 mg dose in the treatment period was not tolerable.
- Primary Outcome Measures
Name Time Method Change From Baseline in Conners' Adult ADHD Rating Scales-Observer: Screening Version (CAARS-O:SV) 18-item ADHD Symptoms Total Score at Day 56 Baseline, 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Premier Psychiatric Research Institute, LLC
🇺🇸Lincoln, Nebraska, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
Center for Psychiatry and Behavioral Medicine Inc.
🇺🇸Las Vegas, Nevada, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Paradigm Research Professionals
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Collaborative Neuroscience Network, LLC
🇺🇸Garden Grove, California, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Orlando, Florida, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Meridien Research
🇺🇸Bradenton, Florida, United States
Southern California Research, LLC
🇺🇸Beverly Hills, California, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
Neuropsychiatric Associates
🇺🇸Woodstock, Vermont, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Jacksonville, Florida, United States
Behavioral Clinical Research, Inc.
🇺🇸North Miami, Florida, United States
BTC of Lincoln
🇺🇸Lincoln, Rhode Island, United States
Aspen Clinical Research
🇺🇸Orem, Utah, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Artemis Institute for Clinical Research
🇺🇸San Marcos, California, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
MCB Clinical Research Centers, LLC
🇺🇸Colorado Springs, Colorado, United States
Eastside Comprehensive Medical Center, LLC.
🇺🇸New York, New York, United States
Oregon Center for Clinical Investigators, Inc.
🇺🇸Salem, Oregon, United States