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

NCT ID: NCT00190879

Last Updated: 2007-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-05-31

Brief Summary

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

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder Comorbid Social Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atomoxetine hydrochloride

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Wildomar, California, United States

Site Status

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.

Bradenton, Florida, United States

Site Status

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Gainesville, Florida, United States

Site Status

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Lexington, Kentucky, United States

Site Status

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Belmont, Massachusetts, United States

Site Status

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Okemos, Michigan, United States

Site Status

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Rochester Hills, Michigan, United States

Site Status

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Saint Charles, Missouri, United States

Site Status

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Nashua, New Hampshire, United States

Site Status

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Cherry Hill, New Jersey, United States

Site Status

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Cedarhurst, New York, United States

Site Status

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New York, New York, United States

Site Status

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Charlotte, North Carolina, United States

Site Status

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Charleston, South Carolina, United States

Site Status

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Houston, Texas, United States

Site Status

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Lake Jackson, Texas, United States

Site Status

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San Antonio, Texas, United States

Site Status

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Burlington, Vermont, United States

Site Status

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Midlothian, Virginia, United States

Site Status

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Middleton, Wisconsin, United States

Site Status

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

Site Status

Countries

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United States Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 25019647 (View on PubMed)

Other Identifiers

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B4Z-US-LYDQ

Identifier Type: -

Identifier Source: secondary_id

9855

Identifier Type: -

Identifier Source: org_study_id