Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174226

Purpose

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	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Atomoxetine Drug: Buspirone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Buspirone hydrochloride Buspirone Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Further study details as provided by Pfizer:

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.

Enrollment:	241
Study Start Date:	November 2004
Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults with ADHD

Exclusion Criteria:

Other Axis I Psychiatric Disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174226

Locations

United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
San Diego, California, United States, 92103-8218
Pfizer Investigational Site
San Diego, California, United States, 92103-8620
Pfizer Investigational Site
San Diego, California, United States, 92103-8656
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32806
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10010
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27705
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Vermont
Pfizer Investigational Site
Woodstock, Vermont, United States, 05091

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A9001245
Study First Received:	September 9, 2005
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00174226 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Atomoxetine
Buspirone
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders

Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Disease
Tranquilizing Agents
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Depressants
Dyskinesias
Pharmacologic Actions
Serotonin Agents
Neurologic Manifestations
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010