Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
NCT ID: NCT00042575
Last Updated: 2006-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2002-06-30
2002-08-31
Brief Summary
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The safety of duloxetine and any side effects that might be associated with it.
Whether duloxetine can help patients with major depression.
It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.
Duloxetine might not have any good effects for you.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Duloxetine
Eligibility Criteria
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Inclusion Criteria
* You must be diagnosed with major depressive disorder
* You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks.
Exclusion Criteria
* You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
* You have a history of alcohol or drug dependence or abuse within the past 6 months.
* You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
* You have a serious medical illness.
18 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Locations
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Trumbull, Connecticut, United States
Lafayette, Indiana, United States
Gaithersburg, Maryland, United States
Belmont, Massachusetts, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
Staten Island, New York, United States
Salt Lake City, Utah, United States
Bellevue, Washington, United States
Countries
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References
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Wohlreich MM, Mallinckrodt CH, Prakash A, Watkin JG, Carter WP. Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation. Depress Anxiety. 2007;24(1):41-52. doi: 10.1002/da.20209.
Other Identifiers
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F1J-US-HMBY
Identifier Type: -
Identifier Source: secondary_id
6475
Identifier Type: -
Identifier Source: org_study_id