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This study has been withdrawn prior to recruitment.

( This study was withdrawn due to business reasons. )

First Received: November 19, 2007 Last Updated: June 19, 2008 History of Changes

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine Reboxetine Reboxetine mesylate

U.S. FDA Resources

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

Additional Information:

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

No publications provided

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

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Psychotropic Drugs
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine
Dyskinesias
Signs and Symptoms

Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Antidepressive Agents
Reboxetine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine
Dyskinesias

Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Central Nervous System Agents
Antidepressive Agents
Reboxetine

ClinicalTrials.gov processed this record on September 10, 2009