Lilly's Emotional and Physical Symptoms of Depression - Full Text View

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

This study has been completed.

First Received: May 25, 2007 No Changes Posted

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00479453

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 IV

MedlinePlus related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Lilly's Emotional and Physical Symptoms of Depression

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 lease 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479453

Locations

Puerto Rico
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Manati, Puerto Rico

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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	8299, F1J-MC-HMCX
Study First Received:	May 25, 2007
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00479453 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors

Duloxetine
Serotonin
Behavioral Symptoms
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder

Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009