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NCT06138691 · ClinicalTrials.gov registry record · Phase 1
KET-RO Plus RO DBT for Treatment Resistant Depression
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT06138691: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT06138691 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06138691, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This pilot study will assess the safety and feasibility of intravenous (IV) ketamine combined with RO DBT in young adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine with this type of therapy.
Primary Outcome
Decrease in depressive symptoms as assessed via the Montgomery and Asberg Depression Rating Scale (MADRS), a clinician-interviewed assessment of depressive symtpoms. Scale ranges from 0-60 with higher scores indicating higher depression severity.
Interventions
- COMBINATION_PRODUCT Ketamine Infusion plus RO DBT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-10-04 |
| Est. Completion | 2025-02-22 |
| Phase | Phase 1 |
What the finished NCT06138691 record still lists
NCT06138691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Ketamine Infusion plus RO DBT is the first listed.
NCT06138691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06138691 about?
NCT06138691 is a clinical study titled "KET-RO Plus RO DBT for Treatment Resistant Depression". This pilot study will assess the safety and feasibility of intravenous (IV) ketamine combined with RO DBT in young adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medic...
What is the current status of trial NCT06138691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-10-04. Estimated completion is 2025-02-22.
What interventions are being tested in trial NCT06138691?
The interventions under investigation include: Ketamine Infusion plus RO DBT (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06138691?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06138691's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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