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

Major Depressive Disorder Clinical Trial

Official title:

Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042575
• Other study ID #: 6475
• Secondary ID: F1J-US-HMBY
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2002
• Last updated: July 18, 2006
• Start date: June 2002
• Est. completion date: August 2002

Study information

• Verified date: July 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Duloxetine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States,