Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

Lilly

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00042562

F1J-US-HMBZ

6476

Details and patient eligibility

About

The purposes of this study are to determine:

The safety of duloxetine and any side effects that might be associated with it.

Whether duloxetine can help patients with major depression.

The safety associated with switching from a medication you may be taking for depression to taking duloxetine.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• You must be at least 18 years old.
• You must have been diagnosed with major depressive disorder.
• You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks

Exclusion criteria

• You are a woman and are pregnant or breastfeeding.
• You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
• You have had a primary diagnosis of an anxiety disorder within the past 6 months.
• You have a history of alcohol or drug dependence or abuse within the past 6 months.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)