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NCT00696293 · ClinicalTrials.gov registry record · Phase 4
Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults
A Phase 4 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT00696293 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 30 participants.
The verdict
NCT00696293, a Phase 4 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG Duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00696293
The ClinicalTrials.gov registry entry for NCT00696293 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Duloxetine is the first listed.
NCT00696293 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00696293 about?
NCT00696293 is a clinical study titled "Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults". 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 ...
What is the current status of trial NCT00696293?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2007-05. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00696293?
The interventions under investigation include: Duloxetine (DRUG).
Who is sponsoring clinical trial NCT00696293?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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