NCT00036335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P50-P75 for phase_3 depression

Timeline
Completed

Started Mar 2002

Shorter than P25 for phase_3 depression

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2002

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
Last Updated

July 19, 2006

Status Verified

July 1, 2006

First QC Date

May 8, 2002

Last Update Submit

July 18, 2006

Conditions

DepressionPain

Keywords

depressionpainbluessadnessaches

Interventions

Duloxetine HydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Unknown Facility

Peoria, Arizona, United States

Location

Unknown Facility

Burbank, California, United States

Location

Unknown Facility

Fresno, California, United States

Location

Unknown Facility

St. Petersburg, Florida, United States

Location

Unknown Facility

West Palm Beach, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Oakbrook Terrace, Illinois, United States

Location

Unknown Facility

Springfield, Illinois, United States

Location

Unknown Facility

Glen Burnie, Maryland, United States

Location

Unknown Facility

Farmington Hills, Michigan, United States

Location

Unknown Facility

Nashua, New Hampshire, United States

Location

Unknown Facility

Clementon, New Jersey, United States

Location

Unknown Facility

Moorestown, New Jersey, United States

Location

Unknown Facility

Albany, New York, United States

Location

Unknown Facility

Olean, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Lake Jackson, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Woodstock, Vermont, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Brown Deer, Wisconsin, United States

Location

Related Publications (2)

  • 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.

    PMID: 25980552DERIVED

  • 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.

    PMID: 25080392DERIVED

MeSH Terms

Conditions

DepressionPain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2002

First Posted

May 10, 2002

Study Start

March 1, 2002

Study Completion

January 1, 2003

Last Updated

July 19, 2006

Record last verified: 2006-07

Locations

US(25)