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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00036309

First Posted: May 9, 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 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	Intervention	Phase
Depressive Disorder	Drug: Duloxetine Hydrochloride	Phase 3


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

Resource links provided by NLM:

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:


Study Start Date:	May 2002
Estimated Study Completion Date:	July 2003

Eligibility

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

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

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

Hudson JI, Perahia DG, Gilaberte I, Wang F, Watkin JG, Detke MJ. Duloxetine in the treatment of major depressive disorder: an open-label study. BMC Psychiatry. 2007 Aug 28;7:43.


ClinicalTrials.gov Identifier:	NCT00036309 History of Changes
Other Study ID Numbers:	4445 F1J-MC-HMBC
First Submitted:	May 8, 2002
First Posted:	May 9, 2002
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

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