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Clinical Trials/NCT00479726
NCT00479726CompletedPhase 4

Lilly's Emotional and Physical Symptoms of Depression Study

Eli Lilly and Company1 site in 1 country8,000 target enrollmentStarted: August 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
8,000
Locations
1
Primary Endpoint
Clinical Global Impression of Severity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

To assess physical and emotional symptoms of depressed patients

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
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
  • •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

Outcomes

Primary Outcomes

Clinical Global Impression of Severity

Somatic Symptom Inventory

Depressive Symptomatology-Self Report

Secondary Outcomes

  • Patient Global Impression of Improvement
  • Mood and Physical Symptoms in Depression
  • Quality of Life Enjoyment Satisfaction Questionnaire-Short form

Investigators

Sponsor Class
Industry

Study Sites (1)

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