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

October 14, 2011 updated by: Abbott

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
    • California
      • Lafayette, California, United States, 94549
      • Oceanside, California, United States, 92056
      • San Diego, California, United States, 92103
    • Colorado
      • Denver, Colorado, United States, 80212
    • Florida
      • Jacksonville, Florida, United States, 32216
      • Maitland, Florida, United States, 32751
      • Miami, Florida, United States, 33173
      • Tampa, Florida, United States, 33606
    • Kansas
      • Newton, Kansas, United States, 67114
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • New Jersey
      • Bridgewater, New Jersey, United States, 10312
    • New York
      • New York, New York, United States, 10010
      • Staten Island, New York, United States, 10312
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
    • Ohio
      • Lyndhurst, Ohio, United States, 44124
    • Oregon
      • Portland, Oregon, United States, 97210
    • South Carolina
      • Charleston, South Carolina, United States, 29405
    • Tennessee
      • Memphis, Tennessee, United States, 38119
    • Texas
      • Lake Jackson, Texas, United States, 77566
    • Virginia
      • Herndon, Virginia, United States, 20170
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Laura Gault, MD,PhD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 20, 2006

First Submitted That Met QC Criteria

October 23, 2006

First Posted (Estimate)

October 24, 2006

Study Record Updates

Last Update Posted (Estimate)

October 18, 2011

Last Update Submitted That Met QC Criteria

October 14, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06-855

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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