Status:
COMPLETED
Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institutes of Health (NIH)
Eli Lilly and Company
Conditions:
Major Depressive Disorder
Back Pain
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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) +...
Detailed Description
This is a two-part study. Step 1 is an 8-week long open-label trial of duloxetine (DUL) + clinical management (CM), titrated up to 90 mg/day, for older adults with comorbid major depressive disorder (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00696293
Start Date
May 1 2007
End Date
April 1 2010
Last Update
February 1 2017
Active Locations (1)
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1
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213