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

This study has been completed.

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00036335

Purpose

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.

Condition	Intervention	Phase
Depression Pain	Drug: Duloxetine Hydrochloride	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment:	286
Study Start Date:	March 2002
Estimated Study Completion Date:	January 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036335

Show 25 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

More Information

Study ID Numbers:	6353, F1J-US-HMCB
Study First Received:	May 8, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00036335
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

depression
pain
blues
sadness
aches

Study placed in the following topic categories:

Dopamine
Depression
Mental Disorders
Mood Disorders
Pain

Depressive Disorder, Major
Depressive Disorder
Serotonin
Duloxetine
Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009