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Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

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.
ClinicalTrials.gov Identifier: NCT00042575
Recruitment Status : Completed
First Posted : August 5, 2002
Last Update Posted : July 19, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:

The Purposes of this Study are to determine:

The safety of duloxetine and any side effects that might be associated with it.

Whether duloxetine can help patients with major depression.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

Duloxetine might not have any good effects for you.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Duloxetine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
Study Start Date : June 2002
Estimated Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • You must be at least 18 years old.
  • You must be diagnosed with major depressive disorder
  • You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks.

Exclusion Criteria:

  • You are a woman and are pregnant or breastfeeding.
  • You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
  • You have a history of alcohol or drug dependence or abuse within the past 6 months.
  • You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
  • 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): NCT00042575


Locations
United States, Connecticut
Trumbull, Connecticut, United States
United States, Indiana
Lafayette, Indiana, United States
United States, Maryland
Gaithersburg, Maryland, United States
United States, Massachusetts
Belmont, Massachusetts, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Staten Island, New York, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Washington
Bellevue, Washington, United States
Sponsors and Collaborators
Eli Lilly and Company
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00042575     History of Changes
Other Study ID Numbers: 6475
F1J-US-HMBY
First Posted: August 5, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006

Keywords provided by Eli Lilly and Company:
Sad, blue, lack of energy, depressed, hopelessness, guilt

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