A Dose-Ranging, Cross-Over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00391729

Purpose

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	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), Dose Comparison, Crossover Assignment, Safety/Efficacy Study
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)

Further study details as provided by Abbott:

Primary Outcome Measures:

Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score [ Time Frame: at the 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: at the final evaluation of each 4-week treatment period ] [ Designated as safety issue: No ]
CAARS ADHD Index, CAARS:Self [ Time Frame: at the final evaluation of each 4-week treatment period ] [ Designated as safety issue: No ]
CGI-ADHD-S, AISRS, TASS, FTND [ Time Frame: at the final evaluation of each 4-week treatment period ] [ Designated as safety issue: No ]
QSU-Brief, CANTAB cognitive battery [ Time Frame: at the final evaluation of each 4-week treatment period ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	October 2006
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo Subjects will take placebo QD, BID for 4-6 weeks
2: Experimental	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

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391729

Show 23 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

George Apostol, MD

Abbott

More Information

Responsible Party:	Abbott ( George Apostol, MD )
Study ID Numbers:	M06-855
Study First Received:	October 20, 2006
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00391729
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

ADHD

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 15, 2009