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Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00122824
First received: July 20, 2005
Last updated: November 5, 2007
Last verified: November 2007

July 20, 2005
November 5, 2007
June 2004
Not Provided
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.
Not Provided
Complete list of historical versions of study NCT00122824 on ClinicalTrials.gov Archive Site
Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Anxiety Disorders
  • Drug: duloxetine hydrochloride
  • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
September 2005
Not Provided

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  • Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Finland,   France,   Germany,   South Africa,   Spain,   Sweden
 
NCT00122824
5075, F1J-MC-HMBR
Not Provided
Not Provided
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