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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 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.
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.
Interventions
- DRUG Placebo
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02378415
The ClinicalTrials.gov registry entry for NCT02378415 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Naval Medical Center, San Diego, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02378415 reports 0 study locations.
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.
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