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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036335
• Other study ID #: 6353
• Secondary ID: F1J-US-HMCB
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2002
• Last updated: July 18, 2006
• Start date: March 2002
• Est. completion date: January 2003

Study information

• Verified date: July 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Pain

Intervention

Drug:
• Duloxetine Hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States,