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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00042575

Enrollment

120

Registered

2002-08-05

Start date

2002-06-30

Completion date

2002-08-31

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

Sad, blue, lack of energy, depressed, hopelessness, guilt

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.

Interventions

DRUGDuloxetine

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

Yes

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.

Countries

United States

Outcome results

None listed

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