CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Ketamine Infusion plus RO DBTcombination
Likely dose
Ketamine Infusion plus RO DBT 0.5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06138691
NCT06138691Phase 1Completed
CompareCT.gov

Medication-assisted Psychotherapy: Using Ketamine-enhanced Radically Open Dialectical Behavior Therapy (RO DBT) to Target Neural and Behavioral Mechanisms of Action in Adults With Moderate to Severe Depression

Washington University School of Medicine·interventional·Posted Nov 18, 2023·Updated Mar 30, 2026

In Brief

A Phase 1 clinical trial evaluating Ketamine Infusion plus RO DBT for Treatment Resistant Depression. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Depression
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedNov 18, 2023
Enrollment StartOct 4, 2023
Primary CompletionJan 11, 2025
Study CompletionFeb 22, 2025
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 2.6 years ago

Interventions

Ketamine Infusion plus RO DBTcombination

The participant will receive 4 weeks of 0.5mg/kg intravenous ketamine given over 40 minutes, as is routinely done in ketamine treatment and four months of RO DBT treatment.