Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Pittsburgh
Collaborators:
Eli Lilly and Company National Institutes of Health (NIH)