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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00036335
First Posted: May 10, 2002
Last Update Posted: July 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  Purpose
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.

Condition Intervention Phase
Depression Pain Drug: Duloxetine Hydrochloride Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Estimated Enrollment: 286
Study Start Date: March 2002
Estimated Study Completion Date: January 2003
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036335


  Show 25 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00036335     History of Changes
Other Study ID Numbers: 6353
F1J-US-HMCB
First Submitted: May 8, 2002
First Posted: May 10, 2002
Last Update Posted: July 19, 2006
Last Verified: July 2006

Keywords provided by Eli Lilly and Company:
depression
pain
blues
sadness
aches

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents