Expired Study
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Durham, North Carolina


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.


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.

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

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

Overall Status:


Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Study Dates

Start Date:May 2002
Completion Date:July 2003
Verification Date:July 2006
Last Changed Date:July 18, 2006
First Received Date:May 8, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Duloxetine Hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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