Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion criteria:

• 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

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