Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)
NCT ID: NCT00479726
Last Updated: 2007-05-28
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
PHASE4
8000 participants
INTERVENTIONAL
2004-08-31
2005-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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duloxetine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Outpatients at least 18 years of age
* Sign the informed consent
* All females must test negative for a urine pregnancy test at visit 1. Females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
* Have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
Exclusion Criteria
* Are employed by Eli Lilly and Company
* Have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
* Current substance dependence, excluding nicotine and caffeine
* Treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an MAOI within 5 days after discontinuation of study drug
* Acute liver injury or severe (Child-Pugh Class C) cirrhosis
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM 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 - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Indianapolis, Indiana, United States
Countries
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References
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Wohlreich MM, Wiltse CG, Desaiah D, Ye W, Robinson RL, Kroenke K, Kornstein SG, Greist JH. Duloxetine in practice-based clinical settings: assessing effects on the emotional and physical symptoms of depression in an open-label, multicenter study. Prim Care Companion J Clin Psychiatry. 2007;9(4):271-9. doi: 10.4088/pcc.v09n0404.
Other Identifiers
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F1J-MC-HMCY
Identifier Type: -
Identifier Source: secondary_id
8300
Identifier Type: -
Identifier Source: org_study_id
NCT00479414
Identifier Type: -
Identifier Source: nct_alias
NCT00479453
Identifier Type: -
Identifier Source: nct_alias