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

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036309
• Other study ID #: 4445
• Secondary ID: F1J-MC-HMBC
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2002
• Last updated: July 18, 2006
• Start date: May 2002
• Est. completion date: July 2003

Study information

• Verified date: July 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Drug:
• Duloxetine Hydrochloride

Locations

Country	Name	City	State
United States	For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States,