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

Tracking Information

First Received Date ^ICMJE

November 19, 2007

Last Updated Date

June 19, 2008

Start Date ^ICMJE

November 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Adult ADHD Investigator Symptom Rating Scale - Total Score [ Time Frame: 4 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00562055 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Attention Deficit Hyperactivity Disorder

Intervention ^ICMJE

Drug: Atomoxetine
Drug: PNU-165442G; [S,S]-reboxetine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Significant comorbid psychiatric diagnoses
Significant risk of suicidal or violent behavior

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00562055

Responsible Party

Director, Clinical Trial Disclosure, Pfizer, Inc.

Study ID Numbers ^ICMJE

A6061060, A6061060

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

June 2008

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