Clinical trial NCT00640185: Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention-Deficit/Hyperactivity Disorder
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: CAARS: Inv Total Score
timeFrame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
Secondary outcomes:
measure: CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self
timeFrame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
measure: TASS, AAQoL, WPAI
timeFrame: Day -1, Day 28, Day 56
measure: BRIEF-A, FTND
timeFrame: Day-1, Day 56
measure: QSU-Brief, Number of Cigarettes smoked per day
timeFrame: Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Site Reference ID/Investigator# 7546
state: California
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 7551
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 7553
state: Florida
city: Overland Park
country: United States
facility: Site Reference ID/Investigator# 7545
state: Kansas
city: Farmington Hills
country: United States
facility: Site Reference ID/Investigator# 7552
state: Michigan
city: Troy
country: United States
facility: Site Reference ID/Investigator# 7548
state: Michigan
city: Eugene
country: United States
facility: Site Reference ID/Investigator# 7554
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 7547
state: Oregon
city: Memphis
country: United States
facility: Site Reference ID/Investigator# 7555
state: Tennessee
city: Virginia Beach
country: United States
facility: Site Reference ID/Investigator# 7549
state: Virginia
city: Bellevue
country: United States
facility: Site Reference ID/Investigator# 7550
state: Washington
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 7631
state: Washington
Study officials:
affiliation: AbbVie
name: Earle Bain
role: STUDY_DIRECTOR
References:
citation: Bain EE, Apostol G, Sangal RB, Robieson WZ, McNeill DL, Abi-Saab WM, Saltarelli MD. A randomized pilot study of the efficacy and safety of ABT-089, a novel alpha4beta2 neuronal nicotinic receptor agonist, in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012 Jun;73(6):783-9. doi: 10.4088/JCP.10m06719.