NCT05950711

Ketamine-Assisted Mindfulness-Based Cognitive Therapy for Depression: A Pilot Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the feasibility of combining IV ketamine, a rapid acting antidepressant, with a course of Mindfulness-Based Cognitive Therapy (MBCT), for the initial and maintenance treatment of depression.

Detailed description

The purpose of this study is to assess the feasibility of combining IV ketamine, a rapid acting antidepressant, with a course of Mindfulness-Based Cognitive Therapy (MBCT), for the initial and maintenance treatment of depression. Both ketamine and MBCT are used for treatment of depression, however, the combination of ketamine and psychotherapy has been studied mostly for drug addiction. Despite its rapid onset and effectiveness for depression, ketamine is most effective in the short term. MBCT is a therapeutic approach that combines cognitive behavioral techniques (CBT) with mindfulness strategies in order to help individuals better understand and manage their thoughts and emotions that can both decrease and prevent the relapse of the symptoms of depression. The aim of this pilot study is to embed one infusion of ketamine in the MBCT treatment. Our hypothesis is that the initial positive effect of ketamine will help patients engage in the behavioral therapy, which itself provides cognitive/emotion control tools to prevent relapses of depression.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
OTHER	Combination use of MBCT and IV Ketamine	Group with Major Depression who will receive a single dose of IV Ketamine embedded within a course of MBCT.

Timeline

• Start date: 2022-03-30
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2023-07-18
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study