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NCT06419439 · ClinicalTrials.gov registry record · Phase 2
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
A Phase 2 study of Depression and Chronic Low Back Pain, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT06419439: Recruiting Phase 2 study of Depression and Chronic Low Back Pain, sponsored by VA Office of Research and Development.
NCT06419439 is a Phase 2 study of Depression and Chronic Low Back Pain that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 44 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06419439, a Phase 2 study of Depression and Chronic Low Back Pain, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression.
Primary Outcome
Pain interference, defined as the extent to which pain impedes enjoyment of and participation in life activities (including cognitive, social, recreational, and self-care activities), will be the primary outcome. Raw scores (range 6 - 30, higher scores indicating more interference) are normed to mean of general population (T-score 50; SD 10); higher T-scores indicate higher pain interference. Minimum clinically important change is 3.0 - 3.5 point reduction in the T-score.
Conditions Studied
Interventions
- DRUG Ketamine hydrochloride
- BEHAVIORAL Minimally Enhanced Usual Care
- BEHAVIORAL Brief narrative intervention
Study Locations (1)
Michigan
- VA Ann Arbor Healthcare System, Ann Arbor, MI - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2025-12-03 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 2 |
What NCT06419439 shows while recruiting
NCT06419439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 3 interventions - of which Ketamine hydrochloride is the first listed.
NCT06419439 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06419439 about?
NCT06419439 is a clinical study titled "Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression". This is a pilot study to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression.
What is the current status of trial NCT06419439?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2025-12-03. Estimated completion is 2029-06-30.
What conditions does trial NCT06419439 study?
This clinical trial studies the following conditions: Depression, Chronic Low Back Pain.
What interventions are being tested in trial NCT06419439?
The interventions under investigation include: Ketamine hydrochloride (DRUG), Minimally Enhanced Usual Care (BEHAVIORAL), Brief narrative intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06419439?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06419439 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06419439's enrollment target sits among peer trials
44 495th of 679 higher than 182 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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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