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

Eli Lilly and Company0 sites286 target enrollmentMarch 2002

ConditionsDepression Pain

DrugsDuloxetine Hydrochloride

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Depression
Sponsor: Eli Lilly and Company
Enrollment: 286
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

January 2003

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

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.