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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.
Information provided by:
Eli Lilly and Company Identifier:
First received: September 12, 2005
Last updated: June 6, 2007
Last verified: June 2007
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
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:

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00190879

  Show 21 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00190879     History of Changes
Other Study ID Numbers: 9855
Study First Received: September 12, 2005
Last Updated: June 6, 2007

Additional relevant MeSH terms:
Anxiety Disorders
Attention Deficit Disorder with Hyperactivity
Phobic Disorders
Pathologic Processes
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on April 26, 2017