Suspended

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

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What is being tested

Combination use of MBCT and IV Ketamine

Other
Who is being recruted

Mental Disorders+1

+ Depressive Disorder, Major

+ Depressive Disorder

From 18 to 65 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: March 2022
See protocol details

Summary

Principal SponsorOhio State University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 30, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleKetamine-Assisted Mindfulness-Based Cognitive Therapy for Depression: A Pilot Study
NCT05950711
Principal SponsorOhio State University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDepressive Disorder, MajorDepressive DisorderMood Disorders

Criteria

6 inclusion criteria required to participate
Adults age 18-65
A current diagnosis of major depressive disorder according to DSM-5 criteria per MINI interview
Moderate to severe level of current depressive symptoms (MADRS score ≥20)
Failure of at least one adequate trial of antidepressant medication (defined as: therapeutic doses of antidepressant medication for ≥ 6 weeks)
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16 exclusion criteria prevent from participating
Meets DSM-5 criteria for bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, active PTSD, dissociative disorders and current substance-induced mood disorder, OCD, eating disorder, panic disorder.
Suicide attempt in the past 4 weeks or current risk of suicide
Current alcohol or drug substance use disorder according to DSM-5
Cognitive- or intellectual impairments which would interfere with participation in MBCT or assessments including meeting criteria for Delirium, Dementia, Amnesia, Cognitive Disorders,
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
One Arm: Combination of MBCT with a single ketamine infusion

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Harding Hospital

Columbus, United StatesOpen Harding Hospital in Google Maps
SuspendedOne Study Center