Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Phase 2

Completed

• Conditions: Attention-Deficit/Hyperactivity Disorder
• Interventions: Drug: ABT-089; Drug: Placebo

• Registration Number: NCT00640185
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-21
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Disposition First Submitted: 2011-08-18
• Disposition First Submitted QC: 2011-08-18
• Disposition First Posted: 2011-08-23
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Have voluntarily signed an informed consent form.
• Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with subject.
• Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
• Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
• Male subjects must agree to comply with applicable contraceptive requirements.
• Subject is able to keep required appointments for clinic visits and all tests, including blood draws and examinations.

Exclusion Criteria

• Subject has a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder.
• Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep disorder requiring treatment of any kind.
• Subject has a history of, or ongoing, serious medical problem.
• Subject has a history of significant allergic reaction to any drug.
• Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
• Subject requires ongoing treatment with any psychiatric medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ABT-089	-
1	Placebo	-
2	ABT-089	-
2	Placebo	-
3	ABT-089	-
3	Placebo	-

Primary Outcome Measures

Name	Time	Method
CAARS: Inv Total Score	Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56

Secondary Outcome Measures

Name	Time	Method
CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self	Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
TASS, AAQoL, WPAI	Day -1, Day 28, Day 56
BRIEF-A, FTND	Day-1, Day 56
QSU-Brief, Number of Cigarettes smoked per day	Day -1, Day 7, Day 14, Day 28, Day 42, Day 56

Trial Locations

Locations (12)

Site Reference ID/Investigator# 7546; 🇺🇸 Lafayette, California, United States

Site Reference ID/Investigator# 7555; 🇺🇸 Memphis, Tennessee, United States

Site Reference ID/Investigator# 7545; 🇺🇸 Overland Park, Kansas, United States

Site Reference ID/Investigator# 7549; 🇺🇸 Virginia Beach, Virginia, United States

Site Reference ID/Investigator# 7551; 🇺🇸 Jacksonville, Florida, United States

Site Reference ID/Investigator# 7554; 🇺🇸 Eugene, Oregon, United States

Site Reference ID/Investigator# 7550; 🇺🇸 Bellevue, Washington, United States

Site Reference ID/Investigator# 7631; 🇺🇸 Seattle, Washington, United States

Site Reference ID/Investigator# 7547; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 7552; 🇺🇸 Farmington Hills, Michigan, United States

Site Reference ID/Investigator# 7553; 🇺🇸 Orlando, Florida, United States

Site Reference ID/Investigator# 7548; 🇺🇸 Troy, Michigan, United States