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

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: May 25, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice-based setting

Condition Intervention Phase
Major Depressive Disorder
Drug: Duloxetine hydrochloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lilly's Emotional and Physical Symptoms of Depression Study

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Clinical Global Impression of Severity
  • Somatic Symptom Inventory
  • Depressive Symptomatology-Self Report

Secondary Outcome Measures:
  • Patient Global Impression of Improvement
  • Mood and physical symptoms in depression
  • Quality of Life Enjoyment and Satisfaction Questionnaire - Short form

Estimated Enrollment: 8000
Study Start Date: August 2004
Study Completion Date: January 2005
Detailed Description:
To assess physical and emotional symptoms of depressed patients

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 live injury or severe (Child-Pugh Class C) cirrhosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00479414

United States, Indiana
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), or speak with your personal physician.
Indianapolis, Indiana, United States
Sponsors and Collaborators
Eli Lilly and Company
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information: Identifier: NCT00479414     History of Changes
Other Study ID Numbers: 7442  F1J-MC-HMCM 
Study First Received: May 25, 2007
Last Updated: May 25, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents processed this record on October 27, 2016