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Completed

NCT Number: NCT00640185

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

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).

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 7546, Lafayette, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-089

Drug

Subjects will take up to two 40 mg tablets once daily for 8 weeks.

Placebo

Drug

Subjects will take one or two placebos once daily for the duration of the study.

Primary outcomes

  1. CAARS: Inv Total Score

    Time frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56

Secondary outcomes

  1. CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self

    Time frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56

  2. TASS, AAQoL, WPAI

    Time frame: Day -1, Day 28, Day 56

  3. BRIEF-A, FTND

    Time frame: Day-1, Day 56

  4. QSU-Brief, Number of Cigarettes smoked per day

    Time frame: Day -1, Day 7, Day 14, Day 28, Day 42, Day 56

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 21, 2008
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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