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

Lilly

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: duloxetine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479726

8300

F1J-MC-HMCY

Details and patient eligibility

About

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

Full description

To assess physical and emotional symptoms of depressed patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)