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Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00036309
Enrollment
Unknown
Registered
2002-05-09
Start date
2002-05-31
Completion date
2003-07-31
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

Depressive Disorder

Keywords

Major Depressive Disorder, Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features

Brief summary

The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.

Interventions

DRUGDuloxetine Hydrochloride

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

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

Inclusion criteria

* Signed the informed consent * Meet criteria for major depressive disorder without psychotic features. * Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel. * Have had at least one other major depressive episode prior to the one being experienced at study entry. * You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol.

Exclusion criteria

* You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry. * Any women who are pregnant or breast feeding. * If you have any serious medical illnesses other than major depressive disorder. * If you have previously participated in a clinical trial for duloxetine. * Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.

Countries

United States

Outcome results

None listed

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