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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Patient must be at least 18 years old.

• Patient must be diagnosed with depression and have had previous episodes of depression.

• Patient must sign informed consent.

Exclusion Criteria:

• Female and pregnant or breastfeeding.

• History of bipolar disorder, schizophrenia, or other psychotic disorders.

• Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization.

• Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study.

• Have taken an antidepressant called fluoxetine within 30 days of the start of the study.