Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Disorder With Hyperactivity
Intervention: Atomoxetine (Drug); Buspirone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adults with ADHD
Exclusion Criteria:
- Other Axis I Psychiatric Disorders
Locations and Contacts
Pfizer Investigational Site, Los Angeles, California 90095, United States
Pfizer Investigational Site, San Diego, California 92103-8218, United States
Pfizer Investigational Site, San Diego, California 92103-8620, United States
Pfizer Investigational Site, San Diego, California 92103-8656, United States
Pfizer Investigational Site, Orlando, Florida 32806, United States
Pfizer Investigational Site, Chicago, Illinois 60637, United States
Pfizer Investigational Site, New York, New York 10010, United States
Pfizer Investigational Site, Durham, North Carolina 27705, United States
Pfizer Investigational Site, Durham, North Carolina 27710, United States
Pfizer Investigational Site, Salt Lake City, Utah 84132, United States
Pfizer Investigational Site, Woodstock, Vermont 05091, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2004
Ending date: January 2006
Last updated: October 16, 2006
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