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

Primary Purpose

Depression, Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Duloxetine Hydrochloride
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, pain, blues, sadness, aches

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 8, 2002
Last Updated
July 18, 2006
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00036335
Brief Title
Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain
Official Title
Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Pain
Keywords
depression, pain, blues, sadness, aches

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
286 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Peoria
State/Province
Arizona
Country
United States
City
Burbank
State/Province
California
Country
United States
City
Fresno
State/Province
California
Country
United States
City
St. Petersburg
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Oakbrook Terrace
State/Province
Illinois
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Glen Burnie
State/Province
Maryland
Country
United States
City
Farmington Hills
State/Province
Michigan
Country
United States
City
Nashua
State/Province
New Hampshire
Country
United States
City
Clementon
State/Province
New Jersey
Country
United States
City
Moorestown
State/Province
New Jersey
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Olean
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Lake Jackson
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Woodstock
State/Province
Vermont
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Brown Deer
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25980552
Citation
Harada E, Kato M, Fujikoshi S, Wohlreich MM, Berggren L, Tokuoka H. Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials. Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16.
Results Reference
derived
PubMed Identifier
25080392
Citation
Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.
Results Reference
derived

Learn more about this trial

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

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