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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01074294
First Posted: February 24, 2010
Last Update Posted: October 30, 2012
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.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
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 Intervention Phase
Attention Deficit Hyperactivity Disorder Drug: OPDC-34712 + Stimulant Therapy Drug: Placebo + Stimulant Therapy Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 740
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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.
  Contacts and Locations
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


  Show 35 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Yan-Ping Zheng, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01074294     History of Changes
Other Study ID Numbers: 331-08-213
First Submitted: February 22, 2010
First Posted: February 24, 2010
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:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs