Status:

COMPLETED

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

Lead Sponsor:

Eli Lilly and Company

Collaborating Sponsors:

Boehringer Ingelheim

Conditions:

Depressive Disorder, Major

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2008

Estimated Enrollment :

514 Patients enrolled

Trial Details

Trial ID

NCT00105989

Start Date

March 1 2005

End Date

January 1 2008

Last Update

July 28 2009

Active Locations (34)

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Page 1 of 9 (34 locations)

1

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Newport Beach, California, United States

2

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sherman Oaks, California, United States

3

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Baltimore, Maryland, United States

4

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Gaithersburg, Maryland, United States