A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Duloxetine; Placebo
Intervention description: Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.; Participants received placebo QD, po for 8 weeks.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 528.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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          -  Previously completed or withdrawn from this study or any other study investigating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