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

This study has been completed.

First Received on May 8, 2002. Last Updated on July 18, 2006 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00036309

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 III

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:

MedlinePlus related topics: Depression Mental Disorders Psychotic Disorders

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Eli Lilly and Company

Additional 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
Study First Received:	May 8, 2002
Last Updated:	July 18, 2006
Health Authority:	United States: Food and Drug Administration

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:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012