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CompletedNCT00429091Updated Nov 2, 2010

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

A Phase 2 interventional study of ABT-894 and atomoxetine in Attention-Deficit/Hyperactivity Disorder and ADHD, sponsored by Abbott. Completed at 22 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-11-02.

Sponsored by Abbott · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
243
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Attention-Deficit/Hyperactivity Disorder
  • ADHD
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 243 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
243 participants (actual)

Study arms

  • Placebo comparator
    1

    Drug: placebo

  • Experimental
    2

    Drug: ABT-894

  • Active comparator
    3

    Drug: atomoxetine

Interventions

  • DrugABT-894

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

  • Drugatomoxetine

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

  • Drugplacebo

    Subjects will take BID for up to four weeks

06

What researchers measure

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

07

Study locations

22 sites
  • Site Reference ID/Investigator# 5965
    San Francisco, California 94143-0984, United States
  • Site Reference ID/Investigator# 5955
    Wildomar, California 92595, United States
  • Site Reference ID/Investigator# 5974
    Orlando, Florida 32806, United States
  • Site Reference ID/Investigator# 5956
    West Palm Beach, Florida 33407, United States
  • Site Reference ID/Investigator# 5973
    Libertyville, Illinois 60048, United States
  • Site Reference ID/Investigator# 5968
    Overland Park, Kansas 66212, United States
  • Site Reference ID/Investigator# 5952
    Rockville, Maryland 20852, United States
  • Site Reference ID/Investigator# 5962
    Boston, Massachusetts 02114, United States
  • Site Reference ID/Investigator# 5954
    Okemos, Michigan 48864, United States
  • Site Reference ID/Investigator# 5970
    Troy, Michigan 48085, United States
  • Site Reference ID/Investigator# 5960
    Clementon, New Jersey 08021, United States
  • Site Reference ID/Investigator# 5963
    Charlotte, North Carolina 28211, United States
  • Site Reference ID/Investigator# 5975
    Eugene, Oregon 97401, United States
  • Site Reference ID/Investigator# 5971
    Philadelphia, Pennsylvania 19149, United States
  • Site Reference ID/Investigator# 5957
    Charleston, South Carolina 29407, United States
  • Site Reference ID/Investigator# 5972
    Austin, Texas 78756, United States
  • Site Reference ID/Investigator# 5959
    Bellaire, Texas 77401, United States
  • Site Reference ID/Investigator# 5969
    San Antonio, Texas 78258, United States
  • Site Reference ID/Investigator# 5951
    Salt Lake City, Utah 84107, United States
  • Site Reference ID/Investigator# 5964
    Burlington, Vermont 05401, United States
  • Site Reference ID/Investigator# 5953
    Virginia Beach, Virginia 23452, United States
  • Site Reference ID/Investigator# 5958
    Bellevue, Washington 98007, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00429091
Lead sponsor
Abbott
First posted
Jan 31, 2007
Start date
Jan 2007
Primary completion
Aug 2007
Last update
Nov 2, 2010

Study contacts

Earle Bain, MD
study director · Abbott
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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