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NCT03889756 · ClinicalTrials.gov registry record · Phase 2
Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy
A Phase 2 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03889756: Clinical Trial Phase 2 study, sponsored by Yale University.
NCT03889756 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03889756, a Phase 2 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the intermediate-term efficacy and tolerability of a multiple-dosing ketamine infusion paradigm for the treatment of medication-refractory major depressive disorder (MDD). We are using a two-phase design. The first phase is a 3-week double blind parallel design clinical trial comparing 6 infusions of ketamine compared to 6 infusions of midazolam in 24 adolescents with treatment resistant depression. The primary outcome of this phase will be Children's Depression Rating Scale (CDRS) score at Day 18. The second phase is a 6-month open phase in which patients who received midazolam and remain depressed with be offered open ketamine treatment (6 infusions over 3 weeks). All participants will be followed weekly for 6 months and tracked for time to relapse.
Primary Outcome
Establish if repeated ketamine will be efficacious medically and psychiatrically, as measured by a significant reduction in CDRS score in those treated with ketamine at the end of the dosing paradigm. The Children's Depression Rating Scale (CDRS) is a clinician-rated instrument with 17 items scored on a 1 to 5 or 1 to 7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. Scores of 20-30 suggest borderline depression. Scores of 40-60 indicate moderate de
Interventions
- DRUG Ketamine infusion
- DRUG Midazolam infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-07-17 |
| Est. Completion | 2023-01-05 |
| Phase | Phase 2 |
Why NCT03889756 stopped before completion
NCT03889756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketamine infusion is the first listed.
NCT03889756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03889756 about?
NCT03889756 is a clinical study titled "Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy". The purpose of this study is to evaluate the intermediate-term efficacy and tolerability of a multiple-dosing ketamine infusion paradigm for the treatment of medication-refractory major depressive disorder (MDD). We are using a two-phase design. The first phase is a 3-week double blind parallel desi...
What is the current status of trial NCT03889756?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2019-07-17. Estimated completion is 2023-01-05.
What interventions are being tested in trial NCT03889756?
The interventions under investigation include: Ketamine infusion (DRUG), Midazolam infusion (DRUG).
Who is sponsoring clinical trial NCT03889756?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03889756's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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