MedTrace Logo

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

NCT00696293 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-02-01

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Duloxetine

Duloxetine up to 120 mg/day + Clinical Management

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eli Lilly and Company

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Jordan F Karp, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-03-31
Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00696293 on ClinicalTrials.gov