A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms

The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for Major Depressive Disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by Mini International Neuropsychiatric Interview (MINI)
* Montgomery-Asberg Depression Rating Scale (MADRS) total score of greater than or equal to 20 during the Screening Phase
* At least 1 previous episode of depression
* Painful physical symptoms with a score greater than or equal to 3 on the Brief Pain Inventory-Short Form (BPI-SF) average pain question during the Screening Phase
* A Clinical Global Impression of Severity (CGI-S) score of greater than or equal to 4 during the Screening Phase
* Written informed consent

Exclusion Criteria:

* Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
* Previously completed or withdrawn from this study or any other study investigating duloxetine
* Women of child-bearing potential who are not using a medically accepted means of contraception
* Any current (within the past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD
* History of alcohol abuse or dependence within 1 year immediately prior to being screened for the study
* Any prior history of bipolar disorder, psychosis, or schizophrenia
* Have an Axis II disorder that would interfere with study compliance
* Lack of a response of any (lifetime of subject) episode of major depression greater than or equal to 2 adequate courses of antidepressant therapy, defined as a clinically appropriate dose for a minimum of 4 weeks or, alternatively, in the judgment of the investigator, the subject meets criteria for treatment-resistant depression
* Have previously received treatment of MDD or Generalized Anxiety Disorder (GAD) with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine
* Diagnosis of acute liver injury or severe cirrhosis
* Uncontrolled narrow-angle glaucoma
* Positive urine drug screen for any substance of abuse.
* A serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or a clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention
* A history of substance abuse or dependence within 1 year before being screened for the study
* History of a serious suicide attempt or subject judged clinically to be at serious suicidal risk
* Require continuous use of opioid analgesics for 6 or more months because of chronic pain
* Pain of a known origin
* Meets criteria for fibromyalgia as defined by the American College of Rheumatology
* Experiences greater than or equal to 1 migraine headache per week
* Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year prior to being screened for the study
* Initiating, changing, or stopping psychotherapy within 6 weeks prior to being screened for the study or at any time during the study
* Investigator or subject anticipates initiating, changing, or stopping non-pharmacologic or alternative therapies for painful physical symptoms at any time during the study
* Are taking any excluded medications within 7 days prior to randomization with the exception of fluoxetine which cannot be taken within 30 days prior to randomization
* Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization or have the potential need to use an MAOI during the study or within 5 days of discontinuing study drug
* Frequent and/or severe allergic reactions with multiple medications
* Abnormal thyroid stimulating hormone concentration
* Has epilepsy or history of seizure disorder or received treatment with anticonvulsant medication for epilepsy or seizures