Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar

NCT00174226

Last updated date
Study Location
Pfizer Investigational Site
Los Angeles, California, 90095, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Attention Deficit Disorder With Hyperactivity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adults with ADHD

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Other Axis I Psychiatric Disorders

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Attention Deficit Disorder With HyperactivityTreatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar NCT00174226
  1. Los Angeles, California
  2. San Diego, California
  3. San Diego, California
  4. San Diego, California
  5. Orlando, Florida
  6. Chicago, Illinois
  7. New York, New York
  8. Durham, North Carolina
  9. Durham, North Carolina
  10. Salt Lake City, Utah
  11. Woodstock, Vermont
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Disorder With Hyperactivity
Intervention  ICMJE
  • Drug: Atomoxetine
  • Drug: Buspirone
Study Arms  ICMJE Not Provided
Publications * Sutherland SM, Adler LA, Chen C, Smith MD, Feltner DE. An 8-week, randomized controlled trial of atomoxetine, atomoxetine plus buspirone, or placebo in adults with ADHD. J Clin Psychiatry. 2012 Apr;73(4):445-50. doi: 10.4088/JCP.10m06788. Epub 2012 Jan 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2008)
241
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
215
Actual Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with ADHD

Exclusion Criteria:

  • Other Axis I Psychiatric Disorders
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174226
Other Study ID Numbers  ICMJE A9001245
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP