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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: Completed Phase 4 study, sponsored by University of Pittsburgh.
NCT00696293 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MADRS is a rating of depression severity with theoretical scale range 0-60, with lower values representing better outcome Larger reduction between MADRS from baseline to 12 weeks would represent better outcome
Interventions
- DRUG Duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
What the finished NCT00696293 record still lists
NCT00696293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Duloxetine is the first listed.
NCT00696293 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00696293's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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