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

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ClinicalTrials.gov Identifier: NCT00479726
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : May 28, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: duloxetine hydrochloride Phase 4

Detailed Description:
To assess physical and emotional symptoms of depressed patients

Study Type : Interventional  (Clinical Trial)
Enrollment : 8000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lilly's Emotional and Physical Symptoms of Depression Study
Study Start Date : August 2004
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Clinical Global Impression of Severity
  2. Somatic Symptom Inventory
  3. Depressive Symptomatology-Self Report

Secondary Outcome Measures :
  1. Patient Global Impression of Improvement
  2. Mood and Physical Symptoms in Depression
  3. Quality of Life Enjoyment Satisfaction Questionnaire-Short form


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479726


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00479726     History of Changes
Obsolete Identifiers: NCT00479414, NCT00479453
Other Study ID Numbers: 8300
F1J-MC-HMCY
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: May 28, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Depression
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents