Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00122824
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : November 6, 2007
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

July 20, 2005
July 22, 2005
November 6, 2007
June 2004
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To assess duloxetine 120 mg once daily is superior to placebo in the treatment of GAD, defined as statistically greater reduction on the mean change anxiety symptoms as measured by the HAMA total score.
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Complete list of historical versions of study NCT00122824 on Archive Site
Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores
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Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder
Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.
This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Anxiety Disorders
  • Drug: duloxetine hydrochloride
  • Drug: placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2005
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Inclusion Criteria:

  • Male and female outpatients at least 18 years of age

Exclusion Criteria:

  • Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine
  • Patient diagnosed with major depressive disorder within the past 6 months
  • Patient diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year
  • History of alcohol or any psychoactive substance abuse or dependence within the past 6 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Finland,   France,   Germany,   South Africa,   Spain,   Sweden,   United States
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Eli Lilly and Company
Boehringer Ingelheim
Study Director: Call 1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
November 2007

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