Switching to Duloxetine in Patients With Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Duloxetine
Intervention description: Study Period II (Acute Therapy): 60 mg capsules, QD, for 4 weeks.
Study Period III (Optimization): Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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.