Overview

Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
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 Phase: Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pittsburgh
Collaborators:
Eli Lilly and Company
National Institutes of Health (NIH)
Treatments:
Duloxetine Hydrochloride
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