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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00479414
First received: May 25, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 ClinicalTrials.gov identifier: NCT00479414

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), 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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov 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:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014