Switching to Duloxetine in Patients With Depression

Attributes of Response in Depressed Patients Switched to Treatment With Duloxetine (ARDENT Study)

The purpose of this study is to help answer the following research question: Whether switching to duloxetine improves depressed mood when current treatment did not work well for patients with depression.

Inclusion Criteria:

• Male or female outpatients aged 18 years or older who meet criteria for Major Depressive Disorder (MDD).
• Currently receiving a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) class of antidepressant for at least a month for the treatment of depression.
• Females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) to test negative for pregnancy based on a urine pregnancy test and to agree to use a reliable method of birth control.

Exclusion Criteria:

• Women who are pregnant or plan to be pregnant or are breastfeeding.
• To have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication.
• Diagnosed with treatment resistant depression.
• History of bipolar disorder, schizophrenia, or other psychotic disorders.
• To have previously taken duloxetine that didn't work.
• Judged to be at serious suicidal risk in the opinion of the investigator and/or score >=3 on Item 3 (suicide) of the 17-Item Hamilton Depression Rating Scale (HAMD-17) at screening (Visit 1) or baseline (Visit 2).
• A serious medical illness that may need treatment during the study.
• Taking certain medications that are not allowed in this study.
• To have a history of alcohol and/or drug abuse or dependence within the past year.
• To have uncontrolled narrow-angle glaucoma.
• To have allergic reactions to many medicines.
• To have undergone "shock" therapy (Electroconvulsive Therapy) or "magnet" treatment (Transcranial Magnetic Stimulation) within the past year.
• To initiate "talk therapy" (psychotherapy) just before or during the study.
• To have chronic pain and you have been taking medicine for it for the last 6 months.
• To have certain liver diseases.
• To have kidney disease or undergoing dialysis.
• Abnormal thyroid stimulating hormone (TSH) concentration.