A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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)
1 other identifier
interventional
221
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2006
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 20, 2006
CompletedFirst Posted
Study publicly available on registry
October 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedOctober 18, 2011
October 1, 2011
8 months
October 20, 2006
October 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score
at the final evaluation of each 4-week treatment period
Secondary Outcomes (4)
CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores
at the final evaluation of each 4-week treatment period
CAARS ADHD Index, CAARS:Self
at the final evaluation of each 4-week treatment period
CGI-ADHD-S, AISRS, TASS, FTND
at the final evaluation of each 4-week treatment period
QSU-Brief, CANTAB cognitive battery
at the final evaluation of each 4-week treatment period
Study Arms (2)
1
PLACEBO COMPARATOR2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (23)
Unknown Facility
Mesa, Arizona, 85210, United States
Unknown Facility
Lafayette, California, 94549, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Denver, Colorado, 80212, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Maitland, Florida, 32751, United States
Unknown Facility
Miami, Florida, 33173, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Newton, Kansas, 67114, United States
Unknown Facility
Farmington Hills, Michigan, 48336, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
Bridgewater, New Jersey, 10312, United States
Unknown Facility
New York, New York, 10010, United States
Unknown Facility
Staten Island, New York, 10312, United States
Unknown Facility
Chapel Hill, North Carolina, 27514, United States
Unknown Facility
Lyndhurst, Ohio, 44124, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Charleston, South Carolina, 29405, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
Lake Jackson, Texas, 77566, United States
Unknown Facility
Herndon, Virginia, 20170, United States
Unknown Facility
Middleton, Wisconsin, 53562, United States
Related Publications (1)
Apostol G, Abi-Saab W, Kratochvil CJ, Adler LA, Robieson WZ, Gault LM, Pritchett YL, Feifel D, Collins MA, Saltarelli MD. Efficacy and safety of the novel alpha(4)beta(2) neuronal nicotinic receptor partial agonist ABT-089 in adults with attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled crossover study. Psychopharmacology (Berl). 2012 Feb;219(3):715-25. doi: 10.1007/s00213-011-2393-2. Epub 2011 Jul 12.
PMID: 21748252DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laura Gault, MD,PhD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2006
First Posted
October 24, 2006
Study Start
October 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
October 18, 2011
Record last verified: 2011-10