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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:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01074294
First received: February 22, 2010
Last updated: October 23, 2012
Last verified: October 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01074294     History of Changes
Other Study ID Numbers: 331-08-213
Study First Received: February 22, 2010
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Inattention
Hyperactivity
Impulsivity
Distractibility
Procrastination
Disorganized
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Central Nervous System Stimulants
Central Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014