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NCT02378415 · ClinicalTrials.gov registry record · Phase 1
Subanesthetic IV Bolus Ketamine in the Treatment of Acute Depression
A Phase 1 study, sponsored by United States Naval Medical Center, San Diego.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02378415: Clinical Trial Phase 1 study, sponsored by United States Naval Medical Center, San Diego.
NCT02378415 is a Phase 1 study that was terminated before completion, run by United States Naval Medical Center, San Diego. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02378415, a Phase 1 study, was terminated before completion, sponsored by United States Naval Medical Center, San Diego.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The objective of this double-blinded placebo-controlled pilot study is to determine whether a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality has a significant rapid antidepressant effect in the acutely depressed population. The study will pursue as a primary outcome measure whether a significant reduction in depressive symptoms, as assessed by the BSS and BHS, occurs shortly after administration of ketamine at 40, 80, 120, and 240 minutes. A secondary outcome measure will be assessed to determine whether this single infusion of ketamine has a sustained reduction in depressive symptoms within 2-weeks post-infusion with a reduction in BDI score. Suicidal ideation will also be assessed for determination of any reduction and sustained reduction post infusion by assessment of the Beck Suicidal Ideation Scale (BSS), Beck Hopelessness Scale (BHS) and Beck Depression Inventory (BDI) at similar intervals.
Primary Outcome
Beck Suicidal Ideation Scale (BSS)
Interventions
- DRUG Placebo
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
Why NCT02378415 stopped before completion
NCT02378415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02378415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02378415 about?
NCT02378415 is a clinical study titled "Subanesthetic IV Bolus Ketamine in the Treatment of Acute Depression". The objective of this double-blinded placebo-controlled pilot study is to determine whether a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality has a significant rapid antidepressant effect in the acutely depressed population...
What is the current status of trial NCT02378415?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT02378415?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG).
Who is sponsoring clinical trial NCT02378415?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02378415's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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