Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00592384 · ClinicalTrials.gov registry record · Phase 4
Project to Improve Symptoms and Mood in People With Spinal Cord Injury
A Phase 4 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 133
- Enrollment target
NCT00592384 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 133 participants.
The verdict
NCT00592384, a Phase 4 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 133 participants
- Enrollment target
Study Summary
Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). Yet no controlled depression treatment trials have been performed in this population. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and major depressive disorder (MDD) or dysthymia who are at least one month post injury. Participants will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan, University of Alabama, Birmingham and Baylor Institute for Rehabilitation, Dallas, TX. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome will be the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes will include changes in pain, health related quality of life depression-related disability and community participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.
Interventions
- DRUG placebo
- DRUG venlafaxine XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2007-07 |
| Est. Completion | 2012-09 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00592384
The ClinicalTrials.gov registry entry for NCT00592384 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00592384 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00592384 about?
NCT00592384 is a clinical study titled "Project to Improve Symptoms and Mood in People With Spinal Cord Injury". Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). Yet no controlled depression treatment trials have been performed in this population. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of v...
What is the current status of trial NCT00592384?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 133 participants. The study started on 2007-07. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00592384?
The interventions under investigation include: placebo (DRUG), venlafaxine XR (DRUG).
Who is sponsoring clinical trial NCT00592384?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.