A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Conditions
-----------------
Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: ABT-089
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet criteria for attention deficit hyperactivity disorder Have voluntarily signed an informed consent 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 have a clinically significant sleep disorder requiring treatment They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers They failed to respond to two or more adequate trials of FDA-approved ADHD medication They have violent, homicidal or suicidal ideation They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome 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 (abuse/dependence) during the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Subjects will take placebo QD, BID for 4-6 weeks<br>|
| Experimental: 2<br> | Drug: ABT-089<br>* Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score |  | at the final evaluation of each 4-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores |  | at the final evaluation of each 4-week treatment period | 
| CAARS ADHD Index, CAARS:Self |  | at the final evaluation of each 4-week treatment period | 
| CGI-ADHD-S, AISRS, TASS, FTND |  | at the final evaluation of each 4-week treatment period | 
| QSU-Brief, CANTAB cognitive battery |  | at the final evaluation of each 4-week treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD