Back to resultsA Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
Attention-Deficit/Hyperactivity Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-089
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder focused on measuring ADHD
Eligibility Criteria
Inclusion Criteria:
- Meet criteria for attention deficit hyperactivity disorder
- Have voluntarily signed an informed consent 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 have a clinically significant sleep disorder requiring treatment
- They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers
- They failed to respond to two or more adequate trials of FDA-approved ADHD medication
- They have violent, homicidal or suicidal ideation
- They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome 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 (abuse/dependence) during the last 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score
Secondary Outcome Measures
CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores
CAARS ADHD Index, CAARS:Self
CGI-ADHD-S, AISRS, TASS, FTND
QSU-Brief, CANTAB cognitive battery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00391729
Brief Title
A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 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-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder
Keywords
ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will take placebo QD, BID for 4-6 weeks
Primary Outcome Measure Information:
Title
Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score
Time Frame
at the final evaluation of each 4-week treatment period
Secondary Outcome Measure Information:
Title
CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores
Time Frame
at the final evaluation of each 4-week treatment period
Title
CAARS ADHD Index, CAARS:Self
Time Frame
at the final evaluation of each 4-week treatment period
Title
CGI-ADHD-S, AISRS, TASS, FTND
Time Frame
at the final evaluation of each 4-week treatment period
Title
QSU-Brief, CANTAB cognitive battery
Time Frame
at the 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 consent 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 have a clinically significant sleep disorder requiring treatment
They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers
They failed to respond to two or more adequate trials of FDA-approved ADHD medication
They have violent, homicidal or suicidal ideation
They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome 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 (abuse/dependence) during the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Gault, MD,PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
10312
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21748252
Citation
Apostol G, Abi-Saab W, Kratochvil CJ, Adler LA, Robieson WZ, Gault LM, Pritchett YL, Feifel D, Collins MA, Saltarelli MD. Efficacy and safety of the novel alpha(4)beta(2) neuronal nicotinic receptor partial agonist ABT-089 in adults with attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled crossover study. Psychopharmacology (Berl). 2012 Feb;219(3):715-25. doi: 10.1007/s00213-011-2393-2. Epub 2011 Jul 12.
Results Reference
derived
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A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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