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Duloxetine for the Treatment of Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00803361
First received: December 3, 2008
Last updated: November 19, 2010
Last verified: November 2010
History of Changes
Results First Received: November 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Generalized Anxiety Disorder
Interventions: Drug: Duloxetine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Duloxetine 60 to 120 mg, capsules, oral, once a day for 15 weeks
Placebo placebo capsules, oral, once a day for 15 weeks

Participant Flow:   Overall Study
    Duloxetine     Placebo  
STARTED     108     102  
COMPLETED     82     74  
NOT COMPLETED     26     28  
Adverse Event                 13                 3  
Lack of Efficacy                 4                 13  
Lost to Follow-up                 1                 2  
Physician Decision                 1                 0  
Protocol Violation                 2                 4  
Withdrawal by Subject                 5                 6  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint   [ Time Frame: Baseline, Week 15 ]
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2.  Secondary:   Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint   [ Time Frame: Baseline, Week 15 ]
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3.  Secondary:   Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint   [ Time Frame: Week 15 ]
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4.  Secondary:   Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint   [ Time Frame: Baseline, Week 15 ]
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5.  Secondary:   Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores   [ Time Frame: Baseline, Week 15 ]
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6.  Secondary:   Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint   [ Time Frame: Baseline, Week 15 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint   [ Time Frame: Baseline, Week 15 ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00803361     History of Changes
Other Study ID Numbers: 11517, F1J-MC-HMFJ
Study First Received: December 3, 2008
Results First Received: November 19, 2010
Last Updated: November 19, 2010
Health Authority: China: Food and Drug Administration