Status:
COMPLETED
Duloxetine for the Treatment of Generalized Anxiety Disorder
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder
Eligibility Criteria
Inclusion
- Psychiatric Diagnosis of generalized anxiety disorder (GAD)
- Outpatients
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD
- Clinical Global Impression (CGI) of Severity Score of at least moderate
- Sheehan Disability Scale (SDS) Global Functioning Impairment Score \>= 12
Exclusion
- Pregnancy or breast feeding
- Serious medical illness
- Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months
- panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year
- lifetime history of bipolar or psychosis
- Any unstable serious medical condition for which duloxetine would not be allowed
- Any use of medications that are not allowed
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00803361
Start Date
December 1 2008
End Date
January 1 2010
Last Update
December 17 2010
Active Locations (7)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beijing, China, 100088
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guangzhou, China, 510370
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hangzhou, China, 310009
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kunming, China, 650032