A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

November 1, 2010 updated by: Abbott

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143-0984
        • Site Reference ID/Investigator# 5965
      • Wildomar, California, United States, 92595
        • Site Reference ID/Investigator# 5955
    • Florida
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 5974
      • West Palm Beach, Florida, United States, 33407
        • Site Reference ID/Investigator# 5956
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Site Reference ID/Investigator# 5973
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Site Reference ID/Investigator# 5968
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Site Reference ID/Investigator# 5952
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Site Reference ID/Investigator# 5962
    • Michigan
      • Okemos, Michigan, United States, 48864
        • Site Reference ID/Investigator# 5954
      • Troy, Michigan, United States, 48085
        • Site Reference ID/Investigator# 5970
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • Site Reference ID/Investigator# 5960
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Site Reference ID/Investigator# 5963
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Site Reference ID/Investigator# 5975
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19149
        • Site Reference ID/Investigator# 5971
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Site Reference ID/Investigator# 5957
    • Texas
      • Austin, Texas, United States, 78756
        • Site Reference ID/Investigator# 5972
      • Bellaire, Texas, United States, 77401
        • Site Reference ID/Investigator# 5959
      • San Antonio, Texas, United States, 78258
        • Site Reference ID/Investigator# 5969
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Site Reference ID/Investigator# 5951
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Site Reference ID/Investigator# 5964
    • Virginia
      • Virginia Beach, Virginia, United States, 23452
        • Site Reference ID/Investigator# 5953
    • Washington
      • Bellevue, Washington, United States, 98007
        • Site Reference ID/Investigator# 5958

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet criteria for attention-deficit/hyperactivity disorder
  • Have voluntarily signed an informed form
  • Are between 18 and 60 years of age
  • Will use contraceptive methods during the study
  • Women must not be pregnant or breast-feeding
  • Must be in generally good health
  • Are fluent in English

Exclusion Criteria:

  • They have a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder or mental retardation
  • They have a current diagnosis of major depressive episode, generalized anxiety disorder (GAD), or post-traumatic stress disorder (PTSD) or has a clinically significant sleep disorder requiring treatment
  • They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants, mood stabilizers, nicotine replacement therapies or varenicline
  • They require ongoing treatment or expected treatment with Coumadin
  • They failed to respond to two or more adequate trials of FDA-approved ADHD medication
  • They have taken atomoxetine during the last 3 months
  • They have violent, homicidal or suicidal ideation
  • They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome, traumatic brain injury, or a central nervous system (CNS) disease, excluding ADHD
  • They have a urine drug screen that is positive for alcohol or drugs of abuse
  • They have a history of substance or alcohol disorder during the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: ABT-894
Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
Placebo Comparator: 1
Drug: placebo
Subjects will take BID for up to four weeks
Active Comparator: 3
Drug: atomoxetine
Subjects will take 40 mg BID or placebo for up to four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)
Time Frame: Final Evaluation of each 4-week Treatment Period
Final Evaluation of each 4-week Treatment Period

Secondary Outcome Measures

Outcome Measure
Time Frame
CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores
Time Frame: Final Evaluation of each 4-week Treatment Period
Final Evaluation of each 4-week Treatment Period
CAARS ADHD Index
Time Frame: Final Evaluation of each 4-week Treatment Period
Final Evaluation of each 4-week Treatment Period
CGI-ADHD-S
Time Frame: Final Evaluation of each 4-week Treatment Period
Final Evaluation of each 4-week Treatment Period
AISRS
Time Frame: Final Evaluation of each 4-week Treatment Period
Final Evaluation of each 4-week Treatment Period
CAARS:Self
Time Frame: Final Evaluation of each 4-week Treatment Period
Final Evaluation of each 4-week Treatment Period
TASS
Time Frame: Final Evaluation of each 4-week Treatment Period
Final Evaluation of each 4-week Treatment Period
FTND
Time Frame: Final Evaluation of each 4-week Treatment Period
Final Evaluation of each 4-week Treatment Period
QSU-Brief
Time Frame: Final Evaluation of each 4-week Treatment Period
Final Evaluation of each 4-week Treatment Period
CANTAB cognitive battery
Time Frame: Final Evaluation of each 4-week Treatment Period
Final Evaluation of each 4-week Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Earle Bain, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 29, 2007

First Submitted That Met QC Criteria

January 29, 2007

First Posted (Estimate)

January 31, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06-818

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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