Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder - Tabular View

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

This study has been completed.

Study NCT00036309. Last updated on July 18, 2006. Information provided by Eli Lilly and Company

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
Official Title ^†	Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
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.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Depressive Disorder
Intervention ^†	Drug: Duloxetine Hydrochloride
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†	May 2002
Completion Date	July 2003
Eligibility 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00036309
Organization ID	4445
Secondary IDs ^††	F1J-MC-HMBC
Study Sponsor ^†	Eli Lilly and Company
Collaborators ^††
Investigators ^†
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
First Received Date ^†	May 8, 2002
Last Updated Date	July 18, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.