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

Major Depressive Disorder Clinical Trial

— LEAPS  

Official title:

Lilly's Emotional and Physical Symptoms of Depression Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479726
• Other study ID #: 8300
• Secondary ID: F1J-MC-HMCY
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2007
• Last updated: May 25, 2007
• Start date: August 2004
• Est. completion date: January 2005

Study information

• Verified date: May 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

To assess physical and emotional symptoms of depressed patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• duloxetine hydrochloride

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression of Severity
Primary	Somatic Symptom Inventory
Primary	Depressive Symptomatology-Self Report
Secondary	Patient Global Impression of Improvement
Secondary	Mood and Physical Symptoms in Depression
Secondary	Quality of Life Enjoyment Satisfaction Questionnaire-Short form

External Links

•   Lilly Clinical Trial Registry