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

Lilly

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Duloxetine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191594

F1J-XM-HMED

9548

Details and patient eligibility

About

A study in patients with depression

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)