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Completed

NCT Number: NCT00479726

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

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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, United States

About this study

To assess physical and emotional symptoms of depressed patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

duloxetine hydrochloride

Drug

Primary outcomes

  1. Clinical Global Impression of Severity

  2. Somatic Symptom Inventory

  3. Depressive Symptomatology-Self Report

Secondary outcomes

  1. Patient Global Impression of Improvement

  2. Mood and Physical Symptoms in Depression

  3. Quality of Life Enjoyment Satisfaction Questionnaire-Short form

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Lilly's Emotional and Physical Symptoms of Depression Study

Acronym: LEAPS

Important dates

Study start
2004
Study completion
2005
First posted
May 28, 2007
Registry last updated
May 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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