Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

Phase 3

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00042575
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

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.

Duloxetine might not have any good effects for you.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-07-31
• Study Completion: 2002-08
• Study First Submitted QC: 2002-08-02
• Study First Posted: 2002-08-05
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-18
• Last Update Posted: 2006-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• You must be at least 18 years old.
• You must be 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 8 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 a history of alcohol or drug dependence or abuse within the past 6 months.
• You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
• You have a serious medical illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP