A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Phase 2

Completed

• Conditions: Attention-Deficit/Hyperactivity Disorder; ADHD
• Interventions: Drug: atomoxetine; Drug: placebo; Drug: ABT-894

• Registration Number: NCT00429091
• Lead Sponsor: Abbott

Brief Summary

A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-29
• Study First Submitted QC: 2007-01-29
• Study First Posted: 2007-01-31
• Primary Completion: 2007-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-11-01
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	atomoxetine	-
1	placebo	-
2	ABT-894	-

Primary Outcome Measures

Name	Time	Method
CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)	Final Evaluation of each 4-week Treatment Period

Secondary Outcome Measures

Name	Time	Method
CAARS ADHD Index	Final Evaluation of each 4-week Treatment Period
CGI-ADHD-S	Final Evaluation of each 4-week Treatment Period
AISRS	Final Evaluation of each 4-week Treatment Period
CAARS:Self	Final Evaluation of each 4-week Treatment Period
CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores	Final Evaluation of each 4-week Treatment Period
TASS	Final Evaluation of each 4-week Treatment Period
FTND	Final Evaluation of each 4-week Treatment Period
QSU-Brief	Final Evaluation of each 4-week Treatment Period
CANTAB cognitive battery	Final Evaluation of each 4-week Treatment Period

Trial Locations

Locations (22)

Site Reference ID/Investigator# 5964; 🇺🇸 Burlington, Vermont, United States

Site Reference ID/Investigator# 5960; 🇺🇸 Clementon, New Jersey, United States

Site Reference ID/Investigator# 5970; 🇺🇸 Troy, Michigan, United States

Site Reference ID/Investigator# 5953; 🇺🇸 Virginia Beach, Virginia, United States

Site Reference ID/Investigator# 5971; 🇺🇸 Philadelphia, Pennsylvania, United States

Site Reference ID/Investigator# 5958; 🇺🇸 Bellevue, Washington, United States

Site Reference ID/Investigator# 5963; 🇺🇸 Charlotte, North Carolina, United States

Site Reference ID/Investigator# 5959; 🇺🇸 Bellaire, Texas, United States

Site Reference ID/Investigator# 5962; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 5968; 🇺🇸 Overland Park, Kansas, United States

Site Reference ID/Investigator# 5965; 🇺🇸 San Francisco, California, United States

Site Reference ID/Investigator# 5969; 🇺🇸 San Antonio, Texas, United States

Site Reference ID/Investigator# 5951; 🇺🇸 Salt Lake City, Utah, United States

Site Reference ID/Investigator# 5955; 🇺🇸 Wildomar, California, United States

Site Reference ID/Investigator# 5974; 🇺🇸 Orlando, Florida, United States

Site Reference ID/Investigator# 5956; 🇺🇸 West Palm Beach, Florida, United States

Site Reference ID/Investigator# 5952; 🇺🇸 Rockville, Maryland, United States

Site Reference ID/Investigator# 5973; 🇺🇸 Libertyville, Illinois, United States

Site Reference ID/Investigator# 5954; 🇺🇸 Okemos, Michigan, United States

Site Reference ID/Investigator# 5972; 🇺🇸 Austin, Texas, United States

Site Reference ID/Investigator# 5975; 🇺🇸 Eugene, Oregon, United States

Site Reference ID/Investigator# 5957; 🇺🇸 Charleston, South Carolina, United States