Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar
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
1 other identifier
interventional
241
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2004
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJuly 15, 2008
July 1, 2008
September 9, 2005
July 10, 2008
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- Adults with ADHD
You may not qualify if:
- Other Axis I Psychiatric Disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (11)
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
Related Publications (1)
Sutherland SM, Adler LA, Chen C, Smith MD, Feltner DE. An 8-week, randomized controlled trial of atomoxetine, atomoxetine plus buspirone, or placebo in adults with ADHD. J Clin Psychiatry. 2012 Apr;73(4):445-50. doi: 10.4088/JCP.10m06788. Epub 2012 Jan 10.
PMID: 22313788DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
November 1, 2004
Study Completion
January 1, 2006
Last Updated
July 15, 2008
Record last verified: 2008-07