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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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ClinicalTrials.gov Identifier: NCT00391729
Recruitment Status : Completed
First Posted : October 24, 2006
Last Update Posted : October 18, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott

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.

Condition or disease Intervention/treatment Phase
Attention-Deficit/Hyperactivity Disorder Drug: ABT-089 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Start Date : October 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
Subjects will take placebo QD, BID for 4-6 weeks
Experimental: 2 Drug: ABT-089
Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks



Primary Outcome Measures :
  1. Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score [ Time Frame: at the final evaluation of each 4-week treatment period ]

Secondary Outcome Measures :
  1. CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores [ Time Frame: at the final evaluation of each 4-week treatment period ]
  2. CAARS ADHD Index, CAARS:Self [ Time Frame: at the final evaluation of each 4-week treatment period ]
  3. CGI-ADHD-S, AISRS, TASS, FTND [ Time Frame: at the final evaluation of each 4-week treatment period ]
  4. QSU-Brief, CANTAB cognitive battery [ Time Frame: at the final evaluation of each 4-week treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391729


  Hide Study Locations
Locations
United States, Arizona
Mesa, Arizona, United States, 85210
United States, California
Lafayette, California, United States, 94549
Oceanside, California, United States, 92056
San Diego, California, United States, 92103
United States, Colorado
Denver, Colorado, United States, 80212
United States, Florida
Jacksonville, Florida, United States, 32216
Maitland, Florida, United States, 32751
Miami, Florida, United States, 33173
Tampa, Florida, United States, 33606
United States, Kansas
Newton, Kansas, United States, 67114
United States, Michigan
Farmington Hills, Michigan, United States, 48336
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, New Jersey
Bridgewater, New Jersey, United States, 10312
United States, New York
New York, New York, United States, 10010
Staten Island, New York, United States, 10312
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Lyndhurst, Ohio, United States, 44124
United States, Oregon
Portland, Oregon, United States, 97210
United States, South Carolina
Charleston, South Carolina, United States, 29405
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
Lake Jackson, Texas, United States, 77566
United States, Virginia
Herndon, Virginia, United States, 20170
United States, Wisconsin
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
Abbott
Investigators
Study Director: Laura Gault, MD,PhD Abbott

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00391729     History of Changes
Other Study ID Numbers: M06-855
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011

Keywords provided by Abbott:
ADHD

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms