Duloxetine for the Treatment of Generalized Anxiety Disorder
NCT ID: NCT00803361
Last Updated: 2010-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
210 participants
INTERVENTIONAL
2008-12-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Duloxetine
Duloxetine
60 to 120 mg, capsules, oral, once a day for 15 weeks
Placebo
Placebo
placebo capsules, oral, once a day for 15 weeks
Interventions
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Duloxetine
60 to 120 mg, capsules, oral, once a day for 15 weeks
Placebo
placebo capsules, oral, once a day for 15 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time(UTC/GMT -5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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
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
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
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.
Nanjing, , China
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.
Shanghai, , China
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.
Xi'an, , China
Countries
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References
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Wu WY, Wang G, Ball SG, Desaiah D, Ang QQ. Duloxetine versus placebo in the treatment of patients with generalized anxiety disorder in China. Chin Med J (Engl). 2011 Oct;124(20):3260-8.
Other Identifiers
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F1J-MC-HMFJ
Identifier Type: OTHER
Identifier Source: secondary_id
11517
Identifier Type: -
Identifier Source: org_study_id