Switching to Duloxetine in Patients With Depression

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

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.