Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

July 18, 2006 updated by: Eli Lilly and Company

Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

The purposes of this study are to determine whether an investigational drug can help patients suffering from major depression with pain symptoms, and gather data on the safety of the investigational drug including any side effects that might be associated with it.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

286

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States
    • California
      • Burbank, California, United States
      • Fresno, California, United States
    • Florida
      • St. Petersburg, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Oakbrook Terrace, Illinois, United States
      • Springfield, Illinois, United States
    • Maryland
      • Glen Burnie, Maryland, United States
    • Michigan
      • Farmington Hills, Michigan, United States
    • New Hampshire
      • Nashua, New Hampshire, United States
    • New Jersey
      • Clementon, New Jersey, United States
      • Moorestown, New Jersey, United States
    • New York
      • Albany, New York, United States
      • Olean, New York, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Toledo, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Austin, Texas, United States
      • Lake Jackson, Texas, United States
      • San Antonio, Texas, United States
    • Vermont
      • Woodstock, Vermont, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Brown Deer, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • You must be suffering from symptoms of depression for at least the past 2 weeks (sadness, loss of interest in daily activities, feelings of hopelessness or guilt, sleeplessness or lack of energy)
  • You must have pain symptoms with no known cause, such as unexplainable, head, chest, or back pain, overall aches and pains, or other unexplainable pains.
  • You need to be available to visit a doctor's office about once a week for 10 weeks.

Exclusion Criteria:

  • You are a woman and are pregnant or breastfeeding.
  • You have a current or previous diagnosis of 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.
  • You have a serious medical illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion

January 1, 2003

Study Registration Dates

First Submitted

May 8, 2002

First Submitted That Met QC Criteria

May 9, 2002

First Posted (Estimate)

May 10, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6353 (Other Grant/Funding Number: FDA Office of Orphan Products Development (OOPD))
  • F1J-US-HMCB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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