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...
Date First Received: September 9, 2005
Last Updated: July 10, 2008
Verified by: Pfizer, July 2008
Clinical Trial Phase: Phase 2 | Start Date: November 2004
Overall Status: Completed
Estimated Enrollment: 241
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Atomoxetine
- Drug: Buspirone
Outcome Measures for this Clinical Trial
Primary 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 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.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Adults with ADHD
Exclusion Criteria:
- Other Axis I Psychiatric Disorders
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00174226
Study ID Number: A9001245
ClinicalTrials.gov Identifier: NCT00174226
Health Authority: United States: Institutional Review Board
To obtain contact information for a study center near you, click here.
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