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OpenTrials
Completed

NCT Number: NCT00190879

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

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

Completed

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Comorbid Social Anxiety Disorder Mental Disorders Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Rio Piedras, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atomoxetine Hydrochloride

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Jun 8, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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