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)

Abbott0 sites221 target enrollmentOctober 2006

ConditionsAttention-Deficit/Hyperactivity Disorder

InterventionsPlacebo ABT-089

DrugsPlacebo ABT-089

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Attention-Deficit/Hyperactivity Disorder
Sponsor: Abbott
Enrollment: 221
Primary Endpoint: Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

June 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Abbott

Responsible Party

Sponsor

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

Arms & Interventions

1

Intervention: Placebo

2

Intervention: ABT-089

Outcomes

Primary Outcomes

Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score

Time Frame: at the final evaluation of each 4-week treatment period

Secondary Outcomes

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)