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

ADHD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429091
• Other study ID #: M06-818
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2007
• Last updated: November 1, 2010
• Start date: January 2007

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• ABT-894
Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
• atomoxetine
Subjects will take 40 mg BID or placebo for up to four weeks.
• placebo
Subjects will take BID for up to four weeks

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 5972	Austin	Texas
United States	Site Reference ID/Investigator# 5959	Bellaire	Texas
United States	Site Reference ID/Investigator# 5958	Bellevue	Washington
United States	Site Reference ID/Investigator# 5962	Boston	Massachusetts
United States	Site Reference ID/Investigator# 5964	Burlington	Vermont
United States	Site Reference ID/Investigator# 5957	Charleston	South Carolina
United States	Site Reference ID/Investigator# 5963	Charlotte	North Carolina
United States	Site Reference ID/Investigator# 5960	Clementon	New Jersey
United States	Site Reference ID/Investigator# 5975	Eugene	Oregon
United States	Site Reference ID/Investigator# 5973	Libertyville	Illinois
United States	Site Reference ID/Investigator# 5954	Okemos	Michigan
United States	Site Reference ID/Investigator# 5974	Orlando	Florida
United States	Site Reference ID/Investigator# 5968	Overland Park	Kansas
United States	Site Reference ID/Investigator# 5971	Philadelphia	Pennsylvania
United States	Site Reference ID/Investigator# 5952	Rockville	Maryland
United States	Site Reference ID/Investigator# 5951	Salt Lake City	Utah
United States	Site Reference ID/Investigator# 5969	San Antonio	Texas
United States	Site Reference ID/Investigator# 5965	San Francisco	California
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# 5956	West Palm Beach	Florida
United States	Site Reference ID/Investigator# 5955	Wildomar	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)		Final Evaluation of each 4-week Treatment Period	No
Secondary	CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores		Final Evaluation of each 4-week Treatment Period	No
Secondary	CAARS ADHD Index		Final Evaluation of each 4-week Treatment Period	No
Secondary	CGI-ADHD-S		Final Evaluation of each 4-week Treatment Period	No
Secondary	AISRS		Final Evaluation of each 4-week Treatment Period	No
Secondary	CAARS:Self		Final Evaluation of each 4-week Treatment Period	No
Secondary	TASS		Final Evaluation of each 4-week Treatment Period	No
Secondary	FTND		Final Evaluation of each 4-week Treatment Period	No
Secondary	QSU-Brief		Final Evaluation of each 4-week Treatment Period	No
Secondary	CANTAB cognitive battery		Final Evaluation of each 4-week Treatment Period	No