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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
September 12, 2005
June 6, 2007
June 2005
Not Provided
Reduction in signs and symptoms of ADHD as measured by the mean changes from baseline to endpoint in Conner's adult ADHD rating scale
Same as current
Complete list of historical versions of study NCT00190879 on ClinicalTrials.gov Archive Site
Reduction in signs and symptoms of social anxiety as measured by the mean changes from baseline to endpoint in Liebowitz social anxiety scale
Same as current
Not Provided
Not Provided
 
Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder
Phase IV 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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder
  • Comorbid Social Anxiety Disorder
  • Drug: Atomoxetine hydrochloride
  • Drug: placebo
Not Provided
Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
440
May 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00190879
9855
B4Z-US-LYDQ
Not Provided
Not Provided
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP