Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 3 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03889756
The ClinicalTrials.gov registry entry for NCT03889756 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketamine infusion is the first listed.
NCT03889756 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.