Expired Study
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Durham, North Carolina


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.


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.


Study is Available At:


Original ID:

4445


NCT ID:

NCT00036309


Secondary ID:

F1J-MC-HMBC


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:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


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:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


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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