Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar

Phase 2

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity

• Registration Number: NCT00174226
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Study Completion: 2006-01
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-10
• Last Update Posted: 2008-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• Adults with ADHD

Exclusion Criteria

• Other Axis I Psychiatric Disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Woodstock, Vermont, United States