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

Lilly

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Duloxetine; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00105989

8606

F1J-MC-HMDI

Details and patient eligibility

About

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.

Enrollment: 514 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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514 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks

Treatment:

Drug: Duloxetine

B

Placebo Comparator group

Description:

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks

Treatment:

Drug: placebo