Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 18, 2008

Last Updated Date

August 29, 2008

Start Date ^†

April 2008

Current Primary Outcome Measures ^†

CAARS: Inv [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
CGI-ADHD-S [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
AISRS [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00640185 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

CAARS: Self [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
TASS [ Time Frame: Day -1, Day 28, Day 56 ] [ Designated as safety issue: No ]
BRIEF-A [ Time Frame: Day-1, Day 56 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Official Title ^†

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).

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Attention-Deficit/Hyperactivity Disorder

Intervention ^†

Drug: ABT-089
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

150

Completion Date

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00640185

Responsible Party

Earle Bain, M.D., Abbott

Secondary IDs ^††

Study Sponsor ^†

Abbott

Collaborators ^††

Investigators ^†

Study Director:

Earle Bain, M.D.

Abbott

Information Provided By

Abbott

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.