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

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.

Timeline

Start

2007-05

Primary completion

2010-03

Completion

2010-04

Publications

• Results Karp JF, Weiner DK, Dew MA, Begley A, Miller MD, Reynolds CF 3rd. Duloxetine and care management treatment of older adults with comorbid major depressive disorder and chronic low back pain: results of an open-label pilot study. Int J Geriatr Psychiatry. 2010 Jun;25(6):633-42. doi: 10.1002/gps.2386.

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Indications