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Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00036309
Recruitment Status : Completed
First Posted : May 9, 2002
Last Update Posted : July 19, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
Study Start Date : May 2002
Study Completion Date : July 2003

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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:   No
Criteria

Inclusion Criteria:

  • Signed the informed consent
  • Meet criteria for major depressive disorder without psychotic features.
  • Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel.
  • Have had at least one other major depressive episode prior to the one being experienced at study entry.
  • You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol.

Exclusion Criteria:

  • You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
  • Any women who are pregnant or breast feeding.
  • If you have any serious medical illnesses other than major depressive disorder.
  • If you have previously participated in a clinical trial for duloxetine.
  • Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00036309


Locations
United States, North Carolina
For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
Durham, North Carolina, United States
Sponsors and Collaborators
Eli Lilly and Company
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00036309     History of Changes
Other Study ID Numbers: 4445
F1J-MC-HMBC
First Posted: May 9, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006

Keywords provided by Eli Lilly and Company:
Major Depressive Disorder
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
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