This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 9, 2005
Last updated: July 10, 2008
Last verified: July 2008
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 Intervention Phase
Attention Deficit Disorder With Hyperactivity Drug: Atomoxetine Drug: Buspirone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 241
Study Start Date: November 2004
Study Completion Date: January 2006

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00174226

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
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00174226     History of Changes
Other Study ID Numbers: A9001245
Study First Received: September 9, 2005
Last Updated: July 10, 2008

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 processed this record on July 19, 2017