NCT00190879
Completed
Phase 4
Phase IV Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Eli Lilly and Company
- Enrollment
- 440
- Locations
- 1
- Primary Endpoint
- Reduction in signs and symptoms of ADHD as measured by the mean changes from baseline to endpoint in Conner's adult ADHD rating scale
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
To investigate the effect of atomoxetine hydrochloride in treating adults who have attention deficit hyperactivity disorder with comorbid social anxiety disorder
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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
- Reduction in signs and symptoms of social anxiety as measured by the mean changes from baseline to endpoint in Liebowitz social anxiety scale
Study Sites (1)
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