A Study in Depression and Associated Painful Physical Symptoms
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Duloxetine; Placebo
Intervention description: Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.; Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 527.0
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:

        Key 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 the Mini International Neuropsychiatric Interview (MINI)

          -  Montgomery-Asberg Depression Rating Scale (MADRS) total score 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

          -  A Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4
             during the Screening Phase

          -  Written informed consent

        Key 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

          -  Have previously completed or withdrawn from this study or any other study
             investigating duloxetine (unless no study drug was received)

          -  Women of child-bearing potential who are not using a medically accepted means of
             contraception

          -  Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than
             MDD

          -  Have a history of alcohol abuse and/or substance abuse or dependence within 1 year
             prior to being screened for the study

          -  Have any prior history of bipolar disorder, psychosis, or schizophrenia

          -  Have an Axis II disorder that would interfere with study compliance

          -  Lack of response of any episode of major depression (lifetime of subject) to two or
             more adequate courses of antidepressant therapy, at a clinically appropriate dose for
             at least 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

          -  Have a serious medical illness, including any cardiovascular, hepatic, renal,
             respiratory, hematologic, endocrinologic, or neurologic disease, or clinically
             significant laboratory abnormality that is not stabilized or is anticipated to require
             intervention, hospitalization, or use of an excluded medication during the study

          -  History of a serious suicide attempt or subject judged clinically to be at serious
             suicidal risk

          -  Requires continuous use of analgesics for 6 or more months because of chronic pain

          -  Has 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 after discontinuation of study drug

          -  Abnormal thyroid stimulating hormone

          -  Has epilepsy or history of seizure disorder or received treatment with anticonvulsant
             medication for epilepsy or seizures