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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190879
First received: September 12, 2005
Last updated: June 6, 2007
Last verified: June 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase IV Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder

Resource links provided by NLM:

U.S. FDA Resources

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

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

No publications provided

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

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013