Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder

This study has been completed.

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00190879

Purpose

To investigate the effect of atomoxetine hydrochloride in treating adults who have attention deficit hyperactivity disorder with comorbid social anxiety disorder

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder Comorbid Social Anxiety Disorder	Drug: Atomoxetine hydrochloride Drug: placebo	Phase IV

MedlinePlus related topics: Anxiety Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase IV Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Reduction in signs and symptoms of ADHD as measured by the mean changes from baseline to endpoint in Conner's adult ADHD rating scale

Secondary Outcome Measures:

Reduction in signs and symptoms of social anxiety as measured by the mean changes from baseline to endpoint in Liebowitz social anxiety scale

Estimated Enrollment:	440
Study Start Date:	June 2005
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

You must be 18 to 65 years old.
You must have been diagnosed with attention deficit hyperactivity disorder and social anxiety disorder.
You must be able to visit the doctor's office at least 8 times over a 16 week period.
You must agree to participate with all tests and examinations that are required for this study.

Exclusion Criteria:

You are a woman and pregnant or breastfeeding.
You presently have an acute or unstable medical illness.
You have a history of allergic reaction to atomoxetine hydrochloride.
You are taking medications that are not permitted in this study. Your physician will discuss these with you.
You have taken part in another clinical research trial within the last 30 days or have received treatment with a drug in the last 30 days that has not received regulatory approval.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190879

Show 21 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours,EST)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	9855, B4Z-US-LYDQ
Study First Received:	September 12, 2005
Last Updated:	June 6, 2007
ClinicalTrials.gov Identifier:	NCT00190879
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Anxiety Disorders
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Atomoxetine

Attention Deficit and Disruptive Behavior Disorders
Neurologic Manifestations
Hyperkinesis
Phobic Disorders
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009