A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety, Tolerability and Efficacy of 40 mg QD and 80 mg QD ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)

AbbVie (prior sponsor, Abbott)12 sites in 1 country160 target enrollmentMarch 2008

ConditionsAttention-Deficit/Hyperactivity Disorder

InterventionsABT-089 Placebo

DrugsABT-089 Placebo

Overview

Phase: Phase 2
Intervention: ABT-089
Conditions: Attention-Deficit/Hyperactivity Disorder
Sponsor: AbbVie (prior sponsor, Abbott)
Enrollment: 160
Locations: 12
Primary Endpoint: CAARS: Inv Total Score
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

August 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AbbVie (prior sponsor, Abbott)

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: ABT-089

1

Intervention: Placebo

2

Intervention: ABT-089

2

Intervention: Placebo

3

Intervention: ABT-089

3

Intervention: Placebo

Outcomes

Primary Outcomes

CAARS: Inv Total Score

Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56

Secondary Outcomes

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)