Clinical trial NCT03324581: The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult Attention Deficit Hyperactivity Disorder
Keywords: ADHD
ADD
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-27
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change From Baseline in Conners' Adult ADHD Rating Scales-Observer: Screening Version (CAARS-O:SV) 18-item ADHD Symptoms Total Score at Day 56
timeFrame: Baseline, Day 56
Secondary outcomes:
Other outcomes:
measure: Change From Baseline in CAARS-O:SV 18-item Score on Days 7, 14, 21, 28, 42, and 56
timeFrame: Baseline, Days 7, 14, 21, 28, 42, and 56
measure: Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) With Adult Prompts Score on Day 28 and Day 56
timeFrame: Baseline, Days 28 and 56
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score on Days 7, 14, 21, 28, 42, and 56
timeFrame: Baseline, Days 7, 14, 21, 28, 42, and 56
measure: Clinical Global Impression-Improvement (CGI-I) Score on Days 7, 14, 21, 28, 42, and 56
timeFrame: Baseline, Days 7, 14, 21, 28, 42, and 56
measure: Change From Baseline in Conners' Adult ADHD Rating Scales-Self-Report: Screening Version (CAARS-S:SV) 18-item Total Score on Days 7, 14, 21, 28, 42, and 56
timeFrame: Baseline, Days 7, 14, 21, 28, 42, and 56
measure: Change From Baseline in Adult ADHD Quality of Life Scale (AAQoL) Total Score on Day 28 and Day 56
timeFrame: Baseline, Days 28, and 56
measure: OPC-64005 Potential for Abuse Liability and Dependence as Assessed by the Drug Effects Questionnaire (DEQ) Score
timeFrame: Baseline, Days 7, 14, 21, 28, 42, and 56
Locations:
city: Beverly Hills
country: United States
facility: Southern California Research, LLC
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: North Miami
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine Inc.
state: Nevada
city: New York
country: United States
facility: Eastside Comprehensive Medical Center, LLC.
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center for Clinical Investigators, Inc.
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigators, Inc.
state: Oregon
city: Lincoln
country: United States
facility: BTC of Lincoln
state: Rhode Island
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
city: Woodstock
country: United States
facility: Neuropsychiatric Associates
state: Vermont
Study officials:
References: