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

Phase 4

Completed

• Conditions: Attention Deficit Hyperactivity Disorder; Comorbid Social Anxiety Disorder

• Registration Number: NCT00190879
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2007-05
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-06
• Last Update Posted: 2007-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

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