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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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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
Total Total of all reporting groups

Baseline Measures
    Duloxetine     Placebo     Total  
Number of Participants  
[units: participants]
 		  108     102     210  
Age  
[units: years]
Mean ± Standard Deviation 		  37.26  ± 11.85     38.02  ± 12.03     37.63  ± 11.92  
Gender  
[units: participants]
 		     
Female     50     56     106  
Male     58     46     104  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     108     102     210  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     0     0     0  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
 		     
China     108     102     210  



  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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Measure Type Primary
Measure Title Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
Measure Description A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Time Frame Baseline, Week 15  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with a baseline and at least one post-baseline result within each treatment group.

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

Measured Values
    Duloxetine     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  107     100  
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint  
[units: Units on a scale]
Mean ± Standard Deviation 		   
Baseline     12.76  ± 2.89     13.56  ± 2.96  
Change from Baseline     -6.38  ± 4.44     -5.29  ± 4.78  


Statistical Analysis 1 for Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.006
Mean Difference (Final Values) [4] -1.62
95% Confidence Interval ( -2.76 to -0.48 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Change = Treatment + Pooled Investigator + Baseline
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p-value is for Change from Baseline.
[4] Other relevant estimation information:
  No text entered.



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
No text entered.  


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