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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
  Purpose

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


Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder
ADHD
 Drug: ABT-894
Drug: atomoxetine
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 243
Study Start Date: January 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
Subjects will take BID for up to four weeks
Other Name: placebo
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.
Other Name: ABT-894
Active Comparator: 3 Drug: atomoxetine
Subjects will take 40 mg BID or placebo for up to four weeks.
Other Name: atomoxetine

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429091

  Show 22 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Earle Bain, MD Abbott
  More Information

No publications provided

Responsible Party: Earle Bain, MD, Abbott
ClinicalTrials.gov Identifier: NCT00429091     History of Changes
Other Study ID Numbers: M06-818
Study First Received: January 29, 2007
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013