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

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This study has been withdrawn prior to recruitment.
( This study was withdrawn due to business reasons. )

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00562055

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Atomoxetine Drug: PNU-165442G; [S,S]-reboxetine	Phase II

MedlinePlus related topics:

Attention Deficit Hyperactivity Disorder

ChemIDplus related topics:

Reboxetine Reboxetine mesylate Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	96
Study Start Date:	November 2007

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562055

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure )
Study ID Numbers:	A6061060, A6061060
First Received:	November 19, 2007
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00562055
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms

Attention Deficit Disorder with Hyperactivity

Mental Disorders

Mental Disorders Diagnosed in Childhood

Atomoxetine

Neurologic Manifestations

Attention Deficit and Disruptive Behavior Disorders

Hyperkinesis

Dyskinesias

Reboxetine

Additional relevant MeSH terms:

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Disease

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Uptake Inhibitors

Nervous System Diseases

Physiological Effects of Drugs

Psychotropic Drugs

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on October 07, 2008