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Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00174226
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 15, 2008
Information provided by:

Brief Summary:
Determine if there is a difference in treatment response for adults with ADHD who are treated with Strattera versus those treated with a combination of Strattera and buspirone

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Atomoxetine Drug: Buspirone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Eight-Week, Double-Blind, 3-Arm Parallel, Placebo-Controlled, Randomized Efficacy And Safety Trial Of Atomoxetine, Atomoxetine Plus Buspirone, And Placebo In Adults With Attention Deficit Hyperactivity Disorder
Study Start Date : November 2004
Actual Study Completion Date : January 2006

Primary Outcome Measures :
  1. To assess the efficacy of Atomoxetine-Buspirone (ATX-BSP) vs placebo (PBO) and atomoxetine (ATX) monotherapy in adult patients with ADHD as measured by the mean change across 7 weeks in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score

Secondary Outcome Measures :
  1. To characterize the safety over 8 weeks of ATX-BSP as compared to PBO and ATX monotherapy. To assess the response rate for the 3 treatment groups based on AISRS and CGI scores.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults with ADHD

Exclusion Criteria:

  • Other Axis I Psychiatric Disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00174226

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United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
San Diego, California, United States, 92103-8218
Pfizer Investigational Site
San Diego, California, United States, 92103-8620
Pfizer Investigational Site
San Diego, California, United States, 92103-8656
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32806
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10010
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27705
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Vermont
Pfizer Investigational Site
Woodstock, Vermont, United States, 05091
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00174226    
Other Study ID Numbers: A9001245
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 15, 2008
Last Verified: July 2008
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents