Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)
Phase 4
Completed
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00479726
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting
- Detailed Description
To assess physical and emotional symptoms of depressed patients
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8000
Inclusion Criteria
Not provided
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical Global Impression of Severity Somatic Symptom Inventory Depressive Symptomatology-Self Report
- Secondary Outcome Measures
Name Time Method Patient Global Impression of Improvement Mood and Physical Symptoms in Depression Quality of Life Enjoyment Satisfaction Questionnaire-Short form
Trial Locations
- Locations (1)
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