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: Completed Phase 4 study, sponsored by University of Washington.
NCT00592384 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 133 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.
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 |
What the finished NCT00592384 record still lists
NCT00592384 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00592384 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00592384's enrollment target sits among peer trials
133 610th of 2000 higher than 1,391 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04276870 · 133 participants · Phase 2
Orphan Indications for CD19 Redirected Autologous T Cells
- NCT04671771 · 133 participants · NA
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
- NCT05610085 · 133 participants · Phase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
- NCT06206486 · 133 participants
The Gut Microbiome and Serum Metabolites As a Biological Mechanism Underlying Pain in Kidney Transplantation
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia