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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00042562
Enrollment
Unknown
Registered
2002-08-05
Start date
2002-12-31
Completion date
2003-12-31
Last updated
2006-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Depressed, blues, sadness, feelings of guilt, hopelessness, lack of energy

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. 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.

Interventions

DRUGduloxetine

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026