Status:
COMPLETED
The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Adult Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Inclusion Criteria (Screening):
- Male and female participants 18 to 55 years of age, inclusive, at the time of informed consent.
- Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of ADHD (including predominantly inattentive presentation, hyperactive presentation, and combined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) v 1.2.
- Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and up to the 30 (+ 2)-day follow-up period.
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2018
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT03324581
Start Date
November 9 2017
End Date
October 31 2018
Last Update
October 29 2021
Active Locations (26)
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1
Southern California Research, LLC
Beverly Hills, California, United States, 90210
2
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
3
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
4
Artemis Institute for Clinical Research
San Marcos, California, United States, 92078