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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00391729
First received: October 20, 2006
Last updated: October 14, 2011
Last verified: October 2011
History of Changes
  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 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-089 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:
  • 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: 221
Study Start Date: October 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Subjects will take placebo QD, BID for 4-6 weeks
Other Name: placebo
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
Other Name: ABT-089

  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: Laura Gault, MD,PhD Abbott
  More Information

No publications provided by Abbott

Additional 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
Study First Received: October 20, 2006
Last Updated: October 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
ADHD

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

ClinicalTrials.gov processed this record on May 19, 2013