Open-Label Duloxetine Extension Phase in Patients Who Have Completed Previous Duloxetine Trials

Phase 3

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00191594
• Lead Sponsor: Eli Lilly and Company

Brief Summary

A study in patients with depression

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-08
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-24
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Male or female patients at least 18 years of age who have previously completed satisfactorily the Lilly sponsored previous clinical trial, and who are clinically controlled with Duloxetine, as judge by the investigator
• All females must test negative for a urine pregnancy test at Visit 1. Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study. Women who are pregnant or breast-feeding may not participate in the study.
• Must sign the informed consent document (ICD).

Exclusion Criteria

• Have received treatment within the last 30 days with a drug ( not including study drug) that has not received regulatory approval for any indication at the time of study entry.
• Patients who have entered the optional tapering period of the previous study.
• In the opinion of the investigator, patients judged to be at serious suicidal risk.
• Treatment with a MAOI within 14 days prior to Visit 1 or potential need to use MAOI during the study or within 5 days of discontinuation of the study drug.
• Any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the Lilly Physician

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse events

Secondary Outcome Measures

Name	Time	Method
Vital signs

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇪🇸 Zamora, Spain