Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)
Completed · Phase 4
Conditions studied: Major Depressive Disorder
In brief
To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting
Key facts
- Study ID
- NCT00479726
- Run by
- Eli Lilly and Company
- People needed
- 8000
- Starts
- 2004-08-01
- Expected to finish
- 2005-01-01
- Last updated by the study team
- 2007-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Meet criteria for major depressive disorder according to the DSM-IV diagnostic 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
You may not qualify if…
- Are investigator site personnel directly affiliated with the study or immediate family
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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