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Duloxetine Compared With Placebo in the Prevention of Relapse in Generalized Anxiety Disorder

NCT ID: NCT00122863

Last Updated: 2007-08-31

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

PHASE3

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-03-31

Brief Summary

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This is a clinical trial assessing the time to relapse of anxiety symptoms among patients with generalized anxiety disorder who have responded to duloxetine therapy.

Detailed Description

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Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Duloxetine Hydrochloride

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients presenting with generalized anxiety disorder (GAD) in the absence of major depressive disorder (MDD). Patients must suffer from GAD and not from an adjustment disorder or anxiety disorder not otherwise specified (NOS). Symptoms of GAD should not be situational in nature.

Exclusion Criteria

* Any current and primary diagnosis other than GAD. Patients diagnosed with or who have a history of MDD within the past 6 months OR patients diagnosed with or who have a history of panic disorder, post-traumatic stress disorder (PTSD), or an eating disorder within the past year OR patients who have been diagnosed with obsessive- compulsive disorder (OCD), bipolar affective disorder, psychosis, factitious disorder or somatoform disorders during their lifetime.
* History of alcohol or any psychoactive substance abuse of dependence (as defined in the DSM-IV-TR) within the past 6 months
* Serious medical illness, including cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator. Clinically significant laboratory abnormalities are those, that, in the judgement of the investigator, indicate a serious medical problem.
* Acute liver injury (such as hepatitis) or severe cirrhosis (Child- Pugh Class C)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 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 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sherman Oaks, California, United States

Site Status

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Fort Myers, Florida, United States

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Atlanta, Georgia, United States

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Libertyville, Illinois, United States

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Prairie Village, Kansas, United States

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Belmont, Massachusetts, United States

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Saint Charles, Missouri, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Allentown, Pennsylvania, United States

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Media, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Charleston, South Carolina, United States

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Lake Jackson, Texas, United States

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Wichita Falls, Texas, United States

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Woodstock, Vermont, United States

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Bellevue, Washington, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Vienna, , Austria

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Aix-en-Provence, , France

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Arcachon, , France

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Bordeaux, , France

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Bourg-des-Comptes, , France

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Caen, , France

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Cherbourg, , France

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Clermont-Ferrand, , France

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Metz, , France

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Montigny-lès-Metz, , France

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Mulhouse, , France

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Orvault, , France

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Rennes, , France

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Berlin, , Germany

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Dresden, , Germany

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Göttingen, , Germany

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Hildesheim, , Germany

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Leipzig, , Germany

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München, , Germany

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Werneck, , Germany

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Almere Stad, , Netherlands

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Nijverdal, , Netherlands

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Rotterdam, , Netherlands

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Coimbra, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Hato Rey, , Puerto Rico

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Ponce, , Puerto Rico

Site Status

Countries

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United States Austria France Germany Netherlands Portugal Puerto Rico

References

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Perlis RH, Fijal B, Dharia S, Houston JP. Pharmacogenetic investigation of response to duloxetine treatment in generalized anxiety disorder. Pharmacogenomics J. 2013 Jun;13(3):280-5. doi: 10.1038/tpj.2011.62. Epub 2012 Jan 17.

Reference Type DERIVED
PMID: 22249355 (View on PubMed)

Other Identifiers

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F1J-MC-HMDV

Identifier Type: -

Identifier Source: secondary_id

7108

Identifier Type: -

Identifier Source: org_study_id