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Completed

NCT Number: NCT00429091

A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 5965, San Francisco, 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

  • Meet criteria for attention-deficit/hyperactivity disorder
  • Have voluntarily signed an informed 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 has a clinically significant sleep disorder requiring treatment
  • They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants, mood stabilizers, nicotine replacement therapies or varenicline
  • They require ongoing treatment or expected treatment with Coumadin
  • They failed to respond to two or more adequate trials of FDA-approved ADHD medication
  • They have taken atomoxetine during the last 3 months
  • They have violent, homicidal or suicidal ideation
  • They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome, traumatic brain injury, 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 during the last 3 months

Treatment and study plan

ABT-894

Drug

Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.

Atomoxetine

Drug

Subjects will take 40 mg BID or placebo for up to four weeks.

Placebo

Drug

Subjects will take BID for up to four weeks

Primary outcomes

  1. CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)

    Time frame: Final Evaluation of each 4-week Treatment Period

Secondary outcomes

  1. CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores

    Time frame: Final Evaluation of each 4-week Treatment Period

  2. CAARS ADHD Index

    Time frame: Final Evaluation of each 4-week Treatment Period

  3. CGI-ADHD-S

    Time frame: Final Evaluation of each 4-week Treatment Period

  4. AISRS

    Time frame: Final Evaluation of each 4-week Treatment Period

  5. CAARS:Self

    Time frame: Final Evaluation of each 4-week Treatment Period

  6. TASS

    Time frame: Final Evaluation of each 4-week Treatment Period

  7. FTND

    Time frame: Final Evaluation of each 4-week Treatment Period

  8. QSU-Brief

    Time frame: Final Evaluation of each 4-week Treatment Period

  9. CANTAB cognitive battery

    Time frame: 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-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Important dates

Study start
2007
Primary completion
2007
First posted
Jan 31, 2007
Registry last updated
Nov 2, 2010

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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