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

Lilly

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder

Treatments: Drug: Duloxetine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00036309

4445

F1J-MC-HMBC

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.