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NCT00174226 Clinical Trial

Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar

Attention Deficit Disorder With Hyperactivity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00174226
Other study ID # A9001245
Secondary ID
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated July 10, 2008
Start date November 2004
Est. completion date January 2006

Study information
Verified date July 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 241
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Adults with ADHD

Exclusion Criteria:

- Other Axis I Psychiatric Disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis

Intervention

Drug:
• Atomoxetine

• Buspirone

Locations
Country Name City State
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Woodstock Vermont

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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.
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