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

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