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Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00122824
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : November 6, 2007
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE July 20, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date November 6, 2007
Study Start Date  ICMJE June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00122824 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2006)
Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder
Official Title  ICMJE Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.
Brief Summary This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Anxiety Disorders
Intervention  ICMJE
  • Drug: duloxetine hydrochloride
  • Drug: placebo
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 12, 2005)
480
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   France,   Germany,   South Africa,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00122824
Other Study ID Numbers  ICMJE 5075
F1J-MC-HMBR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Boehringer Ingelheim
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date November 2007

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