Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
242 participants
INTERVENTIONAL
2008-06-30
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Duloxetine
Patients who met criteria in Study Period I (screening) were treated with duloxetine 60 milligrams (mg) once daily (QD) in an open-label manner for 4 weeks (Study Period II). Study Period II was considered the acute therapy period. Study Period III was a 4-week interval where patients who did not respond during Study Period II had their duloxetine doses optimized to 120 mg.
Duloxetine
Study Period II (Acute Therapy): 60 mg capsules, QD, for 4 weeks.
Study Period III (Optimization): Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.
Interventions
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Duloxetine
Study Period II (Acute Therapy): 60 mg capsules, QD, for 4 weeks.
Study Period III (Optimization): Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently receiving a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) class of antidepressant for at least a month for the treatment of depression.
* Females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) to test negative for pregnancy based on a urine pregnancy test and to agree to use a reliable method of birth control.
Exclusion Criteria
* To have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication.
* Diagnosed with treatment resistant depression.
* History of bipolar disorder, schizophrenia, or other psychotic disorders.
* To have previously taken duloxetine that didn't work.
* Judged to be at serious suicidal risk in the opinion of the investigator and/or score \>=3 on Item 3 (suicide) of the 17-Item Hamilton Depression Rating Scale (HAMD-17) at screening (Visit 1) or baseline (Visit 2).
* A serious medical illness that may need treatment during the study.
* Taking certain medications that are not allowed in this study.
* To have a history of alcohol and/or drug abuse or dependence within the past year.
* To have uncontrolled narrow-angle glaucoma.
* To have allergic reactions to many medicines.
* To have undergone "shock" therapy (Electroconvulsive Therapy) or "magnet" treatment (Transcranial Magnetic Stimulation) within the past year.
* To initiate "talk therapy" (psychotherapy) just before or during the study.
* To have chronic pain and you have been taking medicine for it for the last 6 months.
* To have certain liver diseases.
* To have kidney disease or undergoing dialysis.
* Abnormal thyroid stimulating hormone (TSH) concentration.
18 Years
ALL
No
Sponsors
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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.
Guri-si, , South Korea
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.
Seoul, , South Korea
Countries
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Other Identifiers
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F1J-CR-S022
Identifier Type: OTHER
Identifier Source: secondary_id
12349
Identifier Type: -
Identifier Source: org_study_id