Clinical trial NCT00429091: A Dose-Ranging Study of the Efficacy of ABT-894 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-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention-Deficit/Hyperactivity Disorder
ADHD
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-01-31
Enrollment: 243
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: A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)


Eligibility criteria: Inclusion Criteria:

* Meet criteria for attention-deficit/hyperactivity disorder
* Have voluntarily signed an informed 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 has a clinically significant sleep disorder requiring treatment
* They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants, mood stabilizers, nicotine replacement therapies or varenicline
* They require ongoing treatment or expected treatment with Coumadin
* They failed to respond to two or more adequate trials of FDA-approved ADHD medication
* They have taken atomoxetine during the last 3 months
* They have violent, homicidal or suicidal ideation
* They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome, traumatic brain injury, 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 during the last 3 months

Primary outcomes:
measure: CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)
timeFrame: Final Evaluation of each 4-week Treatment Period
Secondary outcomes:
measure: CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores
timeFrame: Final Evaluation of each 4-week Treatment Period
measure: CAARS ADHD Index
timeFrame: Final Evaluation of each 4-week Treatment Period
measure: CGI-ADHD-S
timeFrame: Final Evaluation of each 4-week Treatment Period
measure: AISRS
timeFrame: Final Evaluation of each 4-week Treatment Period
measure: CAARS:Self
timeFrame: Final Evaluation of each 4-week Treatment Period
measure: TASS
timeFrame: Final Evaluation of each 4-week Treatment Period
measure: FTND
timeFrame: Final Evaluation of each 4-week Treatment Period
measure: QSU-Brief
timeFrame: Final Evaluation of each 4-week Treatment Period
measure: CANTAB cognitive battery
timeFrame: Final Evaluation of each 4-week Treatment Period
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Site Reference ID/Investigator# 5965
state: California
city: Wildomar
country: United States
facility: Site Reference ID/Investigator# 5955
state: California
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 5974
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 5956
state: Florida
city: Libertyville
country: United States
facility: Site Reference ID/Investigator# 5973
state: Illinois
city: Overland Park
country: United States
facility: Site Reference ID/Investigator# 5968
state: Kansas
city: Rockville
country: United States
facility: Site Reference ID/Investigator# 5952
state: Maryland
city: Boston
country: United States
facility: Site Reference ID/Investigator# 5962
state: Massachusetts
city: Okemos
country: United States
facility: Site Reference ID/Investigator# 5954
state: Michigan
city: Troy
country: United States
facility: Site Reference ID/Investigator# 5970
state: Michigan
city: Clementon
country: United States
facility: Site Reference ID/Investigator# 5960
state: New Jersey
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 5963
state: North Carolina
city: Eugene
country: United States
facility: Site Reference ID/Investigator# 5975
state: Oregon
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 5971
state: Pennsylvania
city: Charleston
country: United States
facility: Site Reference ID/Investigator# 5957
state: South Carolina
city: Austin
country: United States
facility: Site Reference ID/Investigator# 5972
state: Texas
city: Bellaire
country: United States
facility: Site Reference ID/Investigator# 5959
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 5969
state: Texas
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 5951
state: Utah
city: Burlington
country: United States
facility: Site Reference ID/Investigator# 5964
state: Vermont
city: Virginia Beach
country: United States
facility: Site Reference ID/Investigator# 5953
state: Virginia
city: Bellevue
country: United States
facility: Site Reference ID/Investigator# 5958
state: Washington
Study officials:
affiliation: Abbott
name: Earle Bain, MD
role: STUDY_DIRECTOR
References: