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

Phase 3

Completed

• Conditions: Depression; Pain

• Registration Number: NCT00036335
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2002-05-08
• Study First Submitted QC: 2002-05-09
• Study First Posted: 2002-05-10
• Study Completion: 2003-01
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-18
• Last Update Posted: 2006-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL