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Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.

This study has been withdrawn prior to recruitment.
Study NCT00562055.   Last updated on June 19, 2008.   Information provided by Pfizer

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Descriptive Information Fields
Brief Title  Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.
Official Title  Phase 2, Randomized, Double-Blind, Parallel-Group, Four Week, Efficacy And Safety Trial Of [S,S]-Reboxetine (PNU-165442g) And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.
Brief Summary

This study will compare the safety and efficacy of [S,S]-reboxetine to atomoxetine in the treatment of adult patients with attention deficity-hyperactivity disorder.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Adult ADHD Investigator Symptom Rating Scale - Total Score [ Time Frame: 4 weeks ]
Secondary Outcome Measure  Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score [ Time Frame: 4 weeks ]
Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score [ Time Frame: 4 weeks ]
Condition  Attention Deficit Hyperactivity Disorder
Intervention  Drug: Atomoxetine
Drug: PNU-165442G; [S,S]-reboxetine
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Withdrawn
Enrollment  96
Start Date  November 2007
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  1. Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-IV criteria.
  2. Score of 24 or higher on the Adult ADHD Investigator Symptom Rating Scale
  3. Score of 4 or higher on the Clinician Global Impression - Severity scale

Exclusion Criteria:

  1. Significant comorbid psychiatric diagnoses
  2. Significant risk of suicidal or violent behavior
Gender Both
Ages 18 Years to 55 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00562055
Organization ID A6061060
Secondary IDs †† A6061060
Study Sponsor  Pfizer
Collaborators ††
Investigators 
Study Director:     Pfizer CT.gov Call Center     Pfizer    
Information Provided By Pfizer
Verification Date June 2008
First Received Date  November 19, 2007
Last Updated Date June 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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