CClinicalTrials.gg
CompletedNCT00042562Updated Jul 19, 2006

Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

A Phase 3 interventional study of duloxetine in Major Depressive Disorder, sponsored by Eli Lilly and Company. Completed at 23 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-07-19.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purposes of this study are to determine:

The safety of duloxetine and any side effects that might be associated with it.

Whether duloxetine can help patients with major depression.

The safety associated with switching from a medication you may be taking for depression to taking duloxetine.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Depressed
  • blues
  • sadness
  • feelings of guilt
  • hopelessness
  • lack of energy
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

Browse Depressive Disorder studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 139 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • You must be at least 18 years old.
  • You must have been diagnosed with major depressive disorder.
  • You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks

Exclusion criteria

Exclusion Criteria:

  • You are a woman and are pregnant or breastfeeding.
  • You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
  • You have had a primary diagnosis of an anxiety disorder within the past 6 months.
  • You have a history of alcohol or drug dependence or abuse within the past 6 months.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • Drugduloxetine
06

Study locations

23 sites
  • Carlsbad, California, United States
  • Los Angeles, California, United States
  • Stanford, California, United States
  • Cromwell, Connecticut, United States
  • Coral Springs, Florida, United States
  • Gainesville, Florida, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Bangor, Maine, United States
  • Boston, Massachusetts, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Cincinnati, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Charlottesville, Virginia, United States
  • Falls Church, Virginia, United States
  • Richmond, Virginia, United States
  • Seattle, Washington, United States
  • West Allis, Wisconsin, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00042562
First posted
Aug 5, 2002
Start date
Dec 2002
Completion
Dec 2003
Last update
Jul 19, 2006
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion