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.

Condition	Treatment or Intervention	Phase
Depressive Disorder, Major	Drug: Duloxetine	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Call Center      1-877-CTLILLY (1-877-285-4559) 

France
      Angouleme,  France
      Fains,  France
      La Rochelle,  France
      Lille Cedex,  France
      Nimes,  France
      Nimes Cedex 4,  France
      Roubaix,  France
      Strasbourg,  France
Germany
      Chemitz,  Germany
      Leipzig,  Germany
      Munchen,  Germany
      Wurzburg,  Germany
      Berlin,  Germany
Italy
      Bari,  Italy
      Catania,  Italy
      Ferrara,  Italy
      Firenze,  Italy
      Parma,  Italy
      Roma,  Italy
      Torino,  Italy
Russian Federation
      Moscow,  Russian Federation
      St Petersburg,  Russian Federation
Sweden
      Halmstad,  Sweden
      Lund,  Sweden
      MALMO,  Sweden
      Stockholm,  Sweden
      SUNDSVALL,  Sweden

Study ID Numbers:  8606
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  March 18, 2005
ClinicalTrials.gov Identifier:  NCT00105989
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08