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Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder (STEP-A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01074294
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in adults with Attention Deficit Hyperactivity Disorder (ADHD) when taken with an approved stimulant medication to explore a possible impact on sleep, quality of life and cognitive function.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: OPDC-34712 + Stimulant Therapy Drug: Placebo + Stimulant Therapy Phase 2

Detailed Description:
Subjects who have been taking prescription medication for ADHD, may be switched to a different one. In addition, subjects will be randomly (by chance) assigned to the investigational medication or placebo (pill without active medication). Total study participation lasts 6-20 weeks (up to 5 months). 675 men and women will be in the study at 40 study centers throughout the U.S.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adult Attention Deficit/ Hyperactivity Disorder
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Sugar pill Drug: Placebo + Stimulant Therapy
Placebo plus a FDA approved stimulant therapy

Experimental: OPC-34712 Drug: OPDC-34712 + Stimulant Therapy
Tablets, Oral, 0.25 or 1.0 mg OPDC-34712 and FDA approved stimulant therapy




Primary Outcome Measures :
  1. To assess the efficacy of adjunctive OPC-34712 (0.25 to 2 mg/day) compared to placebo in adults with ADHD who are identified as incomplete responders to stimulant therapy.To assess the tolerability/safety of adjunctive OPC-34712. [ Time Frame: 11 weeks ]

Secondary Outcome Measures :
  1. To assess the effect of adjunctive OPC-34712 (0.25 to 2 mg/day) compared to placebo on sleep, neurocognitive function, and health outcomes in adults with ADHD who are prospectively identified as incomplete/partial responders to stimulant therapy. [ Time Frame: 11 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female outpatients 18 to 55 years of age, inclusive, at the time of informed consent.
  • Subjects with a primary DSM-IV-TR diagnosis of ADHD (including inattentive, hyperactive, and combined subtypes) as confirmed by the CAADID. Subjects may have received prior treatment for adult ADHD, may be currently receiving treatment for adult ADHD at screening, or may be treatment-naive.
  • Subjects willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period.

Exclusion Criteria:

  • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
  • Subjects with an adequate response, as determined by the investigator, to any stimulant taken for the treatment of adult ADHD after 18 years of age.
  • Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline,antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.
  • Subjects who participated in a clinical trial within the last 180 days or who participated in more than two clinical trials within the past year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074294


Locations
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United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Beverly Hills, California, United States
Irvine, California, United States, 92612
Pasadena, California, United States
San Francisco, California, United States
United States, Florida
Bradenton, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
South Miami, Florida, United States, 33173
United States, Georgia
Atlanta, Georgia, United States
Smyrna, Georgia, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Michigan
Rochester Hills, Michigan, United States
United States, Missouri
St. Charles, Missouri, United States
United States, New Jersey
Cherry Hill, New Jersey, United States
Willingboro, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Dayton, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Texas
Austin, Texas, United States
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Vermont
Woodstock, Vermont, United States
United States, Virginia
Herndon, Virginia, United States
United States, Washington
Bellevue, Washington, United States
Seattle, Washington, United States
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
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Study Director: Yan-Ping Zheng, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01074294    
Other Study ID Numbers: 331-08-213
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Inattention
Hyperactivity
Impulsivity
Distractibility
Procrastination
Disorganized
ADHD
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs