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Completed

NCT Number: NCT00391729

A Dose-Ranging, Cross-over 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.

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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

Mesa, Arizona, 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

  • 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

Treatment and study plan

ABT-089

Drug

Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks

Placebo

Drug

Subjects will take placebo QD, BID for 4-6 weeks

Primary outcomes

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

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

Secondary outcomes

  1. CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores

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

  2. CAARS ADHD Index, CAARS:Self

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

  3. CGI-ADHD-S, AISRS, TASS, FTND

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

  4. QSU-Brief, CANTAB cognitive battery

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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 24, 2006
Registry last updated
Oct 18, 2011

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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