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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00429091
First received: January 29, 2007
Last updated: November 1, 2010
Last verified: September 2010
History of Changes

January 29, 2007
November 1, 2010
January 2007
August 2007   (final data collection date for primary outcome measure)
CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales) [ Time Frame: Final Evaluation of each 4-week Treatment Period ] [ Designated as safety issue: No ]
CAARS:Inv Total Score (sum of Inattentive and Hyperactive/Impulsive Sub-scales) at the final evaluation of each 4-week Treatment Period
Complete list of historical versions of study NCT00429091 on ClinicalTrials.gov Archive Site
  • CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores [ Time Frame: Final Evaluation of each 4-week Treatment Period ] [ Designated as safety issue: No ]
  • CAARS ADHD Index [ Time Frame: Final Evaluation of each 4-week Treatment Period ] [ Designated as safety issue: No ]
  • CGI-ADHD-S [ Time Frame: Final Evaluation of each 4-week Treatment Period ] [ Designated as safety issue: No ]
  • AISRS [ Time Frame: Final Evaluation of each 4-week Treatment Period ] [ Designated as safety issue: No ]
  • CAARS:Self [ Time Frame: Final Evaluation of each 4-week Treatment Period ] [ Designated as safety issue: No ]
  • TASS [ Time Frame: Final Evaluation of each 4-week Treatment Period ] [ Designated as safety issue: No ]
  • FTND [ Time Frame: Final Evaluation of each 4-week Treatment Period ] [ Designated as safety issue: No ]
  • QSU-Brief [ Time Frame: Final Evaluation of each 4-week Treatment Period ] [ Designated as safety issue: No ]
  • CANTAB cognitive battery [ Time Frame: Final Evaluation of each 4-week Treatment Period ] [ Designated as safety issue: No ]
  • CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores
  • CAARS ADHD Index
  • CGI-ADHD-S
  • AISRS
  • CAARS:Self
  • TASS
  • FTND
  • QSU-Brief
  • CANTAB cognitive battery
Not Provided
Not Provided
 
A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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)
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Attention-Deficit/Hyperactivity Disorder
  • ADHD
  • Drug: ABT-894
    Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
    Other Name: ABT-894
  • Drug: atomoxetine
    Subjects will take 40 mg BID or placebo for up to four weeks.
    Other Name: atomoxetine
  • Drug: placebo
    Subjects will take BID for up to four weeks
    Other Name: placebo
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    Intervention: Drug: ABT-894
  • Active Comparator: 3
    Intervention: Drug: atomoxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
Not Provided
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00429091
M06-818
Not Provided
Earle Bain, MD, Abbott
Abbott
Not Provided
Study Director: Earle Bain, MD Abbott
Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP