NCT06138691

KET-RO Plus RO DBT for Treatment Resistant Depression

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Ketamine Infusion plus RO DBT	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.

Timeline

• Start date: 2023-10-04
• Primary completion: 2025-01-11
• Completion: 2025-02-22
• First posted: 2023-11-18
• Last updated: 2026-03-30
• Results posted: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study