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

NCT ID: NCT00036335

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2003-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

depression pain blues sadness aches

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Duloxetine Hydrochloride

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peoria, Arizona, United States

Site Status

Burbank, California, United States

Site Status

Fresno, California, United States

Site Status

St. Petersburg, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Oakbrook Terrace, Illinois, United States

Site Status

Springfield, Illinois, United States

Site Status

Glen Burnie, Maryland, United States

Site Status

Farmington Hills, Michigan, United States

Site Status

Nashua, New Hampshire, United States

Site Status

Clementon, New Jersey, United States

Site Status

Moorestown, New Jersey, United States

Site Status

Albany, New York, United States

Site Status

Olean, New York, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Toledo, Ohio, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Austin, Texas, United States

Site Status

Lake Jackson, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Woodstock, Vermont, United States

Site Status

Richmond, Virginia, United States

Site Status

Seattle, Washington, United States

Site Status

Brown Deer, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25980552 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25080392 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

F1J-US-HMCB

Identifier Type: -

Identifier Source: secondary_id

6353

Identifier Type: -

Identifier Source: org_study_id