Status:
COMPLETED
Switching to Duloxetine in Patients With Depression
Lead Sponsor:
Eli Lilly and Company
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 depressi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00696774
Start Date
June 1 2008
End Date
July 1 2009
Last Update
September 8 2010
Active Locations (2)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guri-si, South Korea, 471-701
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, South Korea, 136 705