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

Tracking Information
First Received Date ^ICMJE	May 8, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE	May 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00036309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Depressive Disorder
Intervention ^ICMJE	Drug: Duloxetine Hydrochloride
Study Arms / Comparison Groups
Publications *	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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	July 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00036309
Responsible Party
Study ID Numbers ^ICMJE	4445, F1J-MC-HMBC
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP