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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00036335
Enrollment
286
Registered
2002-05-10
Start date
2002-03-31
Completion date
2003-01-31
Last updated
2006-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Pain

Keywords

depression, pain, blues, sadness, aches

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.

Interventions

DRUGDuloxetine Hydrochloride

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026