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OpenTrials
Completed

NCT Number: NCT00036335

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peoria, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

duloxetine hydrochloride

Drug

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2003
First posted
May 10, 2002
Registry last updated
Jul 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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