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

NCT00429091 | Completed Phase 2

• 1 other identifier: M06-818
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 22

Brief Summary

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

Conditions

Attention-Deficit/Hyperactivity Disorder; ADHD

Outcome Measures

Primary Outcomes (1)

• CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)

  Final Evaluation of each 4-week Treatment Period

Secondary Outcomes (9)

• CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores

  Final Evaluation of each 4-week Treatment Period

• 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

Study Arms (3)

1

PLACEBO COMPARATOR

Drug: placebo

2

EXPERIMENTAL

Drug: ABT-894

3

ACTIVE COMPARATOR

Drug: atomoxetine

Interventions

ABT-894 DRUG

Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.

2

atomoxetine DRUG

Subjects will take 40 mg BID or placebo for up to four weeks.

3

placebo DRUG

Subjects will take BID for up to four weeks

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (22)

Site Reference ID/Investigator# 5965

San Francisco, California, 94143-0984, United States

Location

Site Reference ID/Investigator# 5955

Wildomar, California, 92595, United States

Location

Site Reference ID/Investigator# 5974

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 5956

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 5973

Libertyville, Illinois, 60048, United States

Location

Site Reference ID/Investigator# 5968

Overland Park, Kansas, 66212, United States

Location

Site Reference ID/Investigator# 5952

Rockville, Maryland, 20852, United States

Location

Site Reference ID/Investigator# 5962

Boston, Massachusetts, 02114, United States

Location

Site Reference ID/Investigator# 5954

Okemos, Michigan, 48864, United States

Location

Site Reference ID/Investigator# 5970

Troy, Michigan, 48085, United States

Location

Site Reference ID/Investigator# 5960

Clementon, New Jersey, 08021, United States

Location

Site Reference ID/Investigator# 5963

Charlotte, North Carolina, 28211, United States

Location

Site Reference ID/Investigator# 5975

Eugene, Oregon, 97401, United States

Location

Site Reference ID/Investigator# 5971

Philadelphia, Pennsylvania, 19149, United States

Location

Site Reference ID/Investigator# 5957

Charleston, South Carolina, 29407, United States

Location

Site Reference ID/Investigator# 5972

Austin, Texas, 78756, United States

Location

Site Reference ID/Investigator# 5959

Bellaire, Texas, 77401, United States

Location

Site Reference ID/Investigator# 5969

San Antonio, Texas, 78258, United States

Location

Site Reference ID/Investigator# 5951

Salt Lake City, Utah, 84107, United States

Location

Site Reference ID/Investigator# 5964

Burlington, Vermont, 05401, United States

Location

Site Reference ID/Investigator# 5953

Virginia Beach, Virginia, 23452, United States

Location

Site Reference ID/Investigator# 5958

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

3-(5,6-dichloropyridin-3-yl)-3,6-diazabicyclo(3.2.0)heptane; Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Earle Bain, MD

  Abbott

  STUDY DIRECTOR

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

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 31, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2007
• Last Updated: November 2, 2010

Record last verified: 2010-09

Locations

US (22)