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COMPLETEDPHASE2

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

A Phase 2, Multicenter, Randomized, Double-blind, Active- and Placebo-controlled Trial of the Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder

NCT03324581•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Locations (26)

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

Key Dates

Start Date

November 9, 2017

Primary Completion Date

October 31, 2018

Completion Date

October 31, 2018

Last Updated

October 29, 2021

Enrollment

239

ACTUAL participants

Conditions

Adult Attention Deficit Hyperactivity Disorder

Interventions

OPC-64005

DRUG

Atomoxetine

DRUG

Placebo

DRUG

Dasotraline Adult ADHD Study

NCT02276209

Adult Attention Deficit Hyperactivity Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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