Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults
Condition: Major Depressive Disorder; Back Pain; Aged
MeSH terms: Back Pain; Low Back Pain; Depressive Disorder; Depressive Disorder, Major
Intervention: Duloxetine
Intervention description: Duloxetine up to 120 mg/day + Clinical Management
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      The following primary hypotheses will be tested:

        1. During Step 1: Major Depressive Disorder (MDD) or Chronic Low Back Pain (CLBP) in < 40%
           of the initial 60 subjects treated with duloxetine (DUL) + Clinical Management(CM)
           during the first 8 weeks will respond (response is defined as a Montgomery Asberg
           Depression Rating Scale (MADRS) score </=9 and at least a 30% improvement in back pain
           as measured with the 20-point numeric rating scale.

        2. During Step 2: More DUL+Problem Solving Therapy for Depression and Pain (PST-DP) than
           DUL+CM treated subjects will achieve response during the second 8 weeks, defined as a
           MADRS score </=9 and at least a 30% improvement in back pain as measured with the
           2-point numeric rating scale.

        3. Improvement in depression scores will be correlated with improvement in CLBP scores.

      The exploratory hypotheses to be tested are that:

      During Step 2: Compared to subjects treated with DUL+CM, subjects treated with DUL+PST-DP
      will have improved outcomes in: 1) disability, 2) sleep, 2) functioning/quality of life, 3)
      caregiver burden/depression, and 5) analgesic use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >/= 60

          -  Current episode of MDD per SCID DSM-IV criteria

          -  Must score >/= 16 on the CES-D assessment

          -  Serum sodium >/=130 mEq/ml

          -  CLBP of at least moderate severity for more days than not for >/= 3 months

          -  MADRS score >/= 15

          -  Sufficiently medically stable to be able to participate in a depression treatment
             protocol

          -  Willingness and ability to speak English Access to translators is limited. It would be
             unsafe to treat an older adult who does not speak English with an antidepressant and
             not be able to effectively communicate with them about their progress and any side
             effects. We provide a 24/7 on-call service for all subjects enrolled in this study.
             The on-call clinicians and physicians are not bilingual, and if a problem arose, it
             may be impossible to effectively interpret and manage the emergent situation. Finally,
             many of the assessments used in the study are self-reports. At the present time, we do
             not have the ability to translate these instruments into other languages. If the
             subject cannot read and understand English, this would interfere with their ability to
             complete the self-report assessments

          -  Willingness to discontinue other antidepressants and anxiolytics, except for lorazepam
             up to 2 mg/day

          -  Mini Mental State Exam > 20

          -  Willingness to provide informed consent

          -  Corrected visual ability that enables reading of newspaper headlines and hearing
             capacity that is adequate to respond to a raised conversational voice.

        Exclusion Criteria:

          -  Meet DSM-IV criteria for dementia

          -  History of bipolar, schizophrenia, schizoaffective, or other psychotic disorder

          -  Alcohol or other drug abuse (including abuse of prescription medications) within the
             past 6 months

          -  History of treatment non-adherence in other protocols run by the Mid-Life or Late-Life
             Centers

          -  Acute pain superimposed on chronic pain. For example, subjects who report "red flags"
             which suggest a herniated disk, vertebral fracture, infection, cauda equina syndrome,
             or other medical emergency will be excluded

          -  Wheelchair bound

          -  History of documented non-response to duloxetine

          -  Concurrent use of thioridazine

          -  Active suicidal ideation with plan

          -  Uncontrolled narrow angle glaucoma