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

Primary Purpose

Attention-Deficit/Hyperactivity Disorder, ADHD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-894
atomoxetine
placebo
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 5965
  • Site Reference ID/Investigator# 5955
  • Site Reference ID/Investigator# 5974
  • Site Reference ID/Investigator# 5956
  • Site Reference ID/Investigator# 5973
  • Site Reference ID/Investigator# 5968
  • Site Reference ID/Investigator# 5952
  • Site Reference ID/Investigator# 5962
  • Site Reference ID/Investigator# 5954
  • Site Reference ID/Investigator# 5970
  • Site Reference ID/Investigator# 5960
  • Site Reference ID/Investigator# 5963
  • Site Reference ID/Investigator# 5975
  • Site Reference ID/Investigator# 5971
  • Site Reference ID/Investigator# 5957
  • Site Reference ID/Investigator# 5972
  • Site Reference ID/Investigator# 5959
  • Site Reference ID/Investigator# 5969
  • Site Reference ID/Investigator# 5951
  • Site Reference ID/Investigator# 5964
  • Site Reference ID/Investigator# 5953
  • Site Reference ID/Investigator# 5958

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)

Secondary Outcome Measures

CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores
CAARS ADHD Index
CGI-ADHD-S
AISRS
CAARS:Self
TASS
FTND
QSU-Brief
CANTAB cognitive battery

Full Information

First Posted
January 29, 2007
Last Updated
November 1, 2010
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00429091
Brief Title
A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder, ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ABT-894
Intervention Description
Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
Intervention Type
Drug
Intervention Name(s)
atomoxetine
Intervention Description
Subjects will take 40 mg BID or placebo for up to four weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects will take BID for up to four weeks
Primary Outcome Measure Information:
Title
CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)
Time Frame
Final Evaluation of each 4-week Treatment Period
Secondary Outcome Measure Information:
Title
CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores
Time Frame
Final Evaluation of each 4-week Treatment Period
Title
CAARS ADHD Index
Time Frame
Final Evaluation of each 4-week Treatment Period
Title
CGI-ADHD-S
Time Frame
Final Evaluation of each 4-week Treatment Period
Title
AISRS
Time Frame
Final Evaluation of each 4-week Treatment Period
Title
CAARS:Self
Time Frame
Final Evaluation of each 4-week Treatment Period
Title
TASS
Time Frame
Final Evaluation of each 4-week Treatment Period
Title
FTND
Time Frame
Final Evaluation of each 4-week Treatment Period
Title
QSU-Brief
Time Frame
Final Evaluation of each 4-week Treatment Period
Title
CANTAB cognitive battery
Time Frame
Final Evaluation of each 4-week Treatment Period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Earle Bain, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 5965
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0984
Country
United States
Facility Name
Site Reference ID/Investigator# 5955
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
Site Reference ID/Investigator# 5974
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 5956
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Site Reference ID/Investigator# 5973
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Site Reference ID/Investigator# 5968
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Site Reference ID/Investigator# 5952
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Site Reference ID/Investigator# 5962
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Site Reference ID/Investigator# 5954
City
Okemos
State/Province
Michigan
ZIP/Postal Code
48864
Country
United States
Facility Name
Site Reference ID/Investigator# 5970
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Site Reference ID/Investigator# 5960
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Site Reference ID/Investigator# 5963
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Site Reference ID/Investigator# 5975
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Site Reference ID/Investigator# 5971
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
Site Reference ID/Investigator# 5957
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Site Reference ID/Investigator# 5972
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Site Reference ID/Investigator# 5959
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Site Reference ID/Investigator# 5969
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Site Reference ID/Investigator# 5951
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Site Reference ID/Investigator# 5964
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Site Reference ID/Investigator# 5953
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Site Reference ID/Investigator# 5958
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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