Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00174226

Collaborator

(none)

241

Enrollment

Locations

Duration (Months)

21.9

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Atomoxetine Drug: Buspirone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

241 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2004

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome 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 Outcome 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults with ADHD

Exclusion Criteria:

Other Axis I Psychiatric Disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Los Angeles	California	United States	90095
2	Pfizer Investigational Site	San Diego	California	United States	92103-8218
3	Pfizer Investigational Site	San Diego	California	United States	92103-8620
4	Pfizer Investigational Site	San Diego	California	United States	92103-8656
5	Pfizer Investigational Site	Orlando	Florida	United States	32806
6	Pfizer Investigational Site	Chicago	Illinois	United States	60637
7	Pfizer Investigational Site	New York	New York	United States	10010
8	Pfizer Investigational Site	Durham	North Carolina	United States	27705
9	Pfizer Investigational Site	Durham	North Carolina	United States	27710
10	Pfizer Investigational Site	Salt Lake City	Utah	United States	84132
11	Pfizer Investigational Site	Woodstock	Vermont	United States	05091