Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00640185

Purpose

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

Condition	Intervention	Phase
Attention-Deficit/Hyperactivity Disorder	Drug: ABT-089 Drug: Placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Abbott:

Primary Outcome Measures:

CAARS: Inv [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
CGI-ADHD-S [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
AISRS [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CAARS: Self [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
TASS [ Time Frame: Day -1, Day 28, Day 56 ] [ Designated as safety issue: No ]
BRIEF-A [ Time Frame: Day-1, Day 56 ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	April 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: ABT-089 Subjects will take up to two 40 mg tablets once daily for 8 weeks. Drug: Placebo Subjects will take one or two placebos once daily for the duration of the study.
2: Experimental	Drug: ABT-089 Subjects will take up to two 40 mg tablets once daily for 8 weeks. Drug: Placebo Subjects will take one or two placebos once daily for the duration of the study.
3: Experimental	Drug: ABT-089 Subjects will take up to two 40 mg tablets once daily for 8 weeks. Drug: Placebo Subjects will take one or two placebos once daily for the duration of the study.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have voluntarily signed an informed consent form.
Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with subject.
Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
Male subjects must agree to comply with applicable contraceptive requirements.
Subject is able to keep required appointments for clinic visits and all tests, including blood draws and examinations.

Exclusion Criteria:

Subject has a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder.
Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep disorder requiring treatment of any kind.
Subject has a history of, or ongoing, serious medical problem.
Subject has a history of significant allergic reaction to any drug.
Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
Subject requires ongoing treatment with any psychiatric medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640185

Locations

United States, California

Lafayette, California, United States, 94549
United States, Florida

Orlando, Florida, United States, 32806

Jacksonville, Florida, United States, 32216
United States, Kansas

Overland Park, Kansas, United States, 66212
United States, Michigan

Farmington Hills, Michigan, United States, 48336

Troy, Michigan, United States, 48085
United States, Oregon

Eugene, Oregon, United States, 97401

Portland, Oregon, United States, 97210
United States, Tennessee

Memphis, Tennessee, United States, 38119
United States, Virginia

Virginia Beach, Virginia, United States, 23452
United States, Washington

Bellevue, Washington, United States, 98004

Seattle, Washington, United States, 98104

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Earle Bain, M.D.

Abbott

More Information

Responsible Party:	Abbott ( Earle Bain, M.D. )
Study ID Numbers:	M10-346
Study First Received:	March 18, 2008
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00640185
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009