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

Phase 3

Completed

• Conditions: Depressive Disorder

• Registration Number: NCT00036309
• Lead Sponsor: Eli Lilly and Company

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

Not available

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-05-08
• Study First Submitted QC: 2002-05-08
• Study First Posted: 2002-05-09
• Study Completion: 2003-07
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-18
• Last Update Posted: 2006-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559); 🇺🇸 Durham, North Carolina, United States