Clinical trial NCT00391729: A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-10-24
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score
timeFrame: at the final evaluation of each 4-week treatment period
Secondary outcomes:
measure: CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores
timeFrame: at the final evaluation of each 4-week treatment period
measure: CAARS ADHD Index, CAARS:Self
timeFrame: at the final evaluation of each 4-week treatment period
measure: CGI-ADHD-S, AISRS, TASS, FTND
timeFrame: at the final evaluation of each 4-week treatment period
measure: QSU-Brief, CANTAB cognitive battery
timeFrame: at the final evaluation of each 4-week treatment period
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Lafayette
country: United States
state: California
city: Oceanside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Newton
country: United States
state: Kansas
city: Farmington Hills
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Bridgewater
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Lyndhurst
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Lake Jackson
country: United States
state: Texas
city: Herndon
country: United States
state: Virginia
city: Middleton
country: United States
state: Wisconsin
Study officials:
affiliation: Abbott
name: Laura Gault, MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.