The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Adult Attention Deficit Hyperactivity Disorder

In brief

A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.

Key facts

Study ID

NCT03324581

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

239

Starts

2017-11-09

Expected to finish

2018-10-31

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• 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
• Clinical Neuroscience Solutions Inc. — Orlando, Florida, United States
• iResearch Atlanta — Decatur, Georgia, United States
• Northwest Behavioral Research Center — Marietta, Georgia, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• Premier Psychiatric Research Institute, LLC — Lincoln, Nebraska, United States
• Center for Psychiatry and Behavioral Medicine Inc. — Las Vegas, Nevada, United States
• Eastside Comprehensive Medical Center, LLC. — New York, New York, United States
• The Medical Research Network, LLC — New York, New York, United States
• IPS Research Company — Oklahoma City, Oklahoma, United States
• Paradigm Research Professionals — Oklahoma City, Oklahoma, United States
• Oregon Center for Clinical Investigators, Inc. — Portland, Oregon, United States
• Oregon Center for Clinical Investigators, Inc. — Salem, Oregon, United States
• BTC of Lincoln — Lincoln, Rhode Island, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• Aspen Clinical Research — Orem, Utah, United States

Full record on ClinicalTrials.gov

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