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

This open-label feasibility study (n=21) will assess the combination of IV ketamine with Mindfulness-Based Cognitive Therapy (MBCT) for the treatment of depression.

The study, conducted by Ohio State University, aims to determine the feasibility of integrating a single infusion of ketamine into MBCT for both initial and maintenance depression treatment. While ketamine is known for its rapid antidepressant effects, its long-term efficacy is limited. MBCT, combining cognitive behavioral techniques with mindfulness strategies, aims to prevent depression relapse.

This pilot study hypothesizes that ketamine’s initial positive effects will enhance patient engagement in MBCT, providing cognitive and emotional control tools to prevent depression relapses.

Participants aged 18-65 with a diagnosis of major depressive disorder and moderate to severe depressive symptoms will receive the intervention.

Primary outcome measures include changes in depressive symptoms measured by the MADRS score, with secondary outcomes including changes in depressive symptoms measured by the PHQ9 score and correlations between depression scores and mystical experiences during ketamine infusion. The study started in March 2022 and is estimated to be completed in November 2023.

Topic Depression
Compound Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 30 March 2022
End date 30 November 2023
Phase Phase IV
Design Open
Type Interventional
Generation First
Participants 21
Sex All
Age 18- 65
Therapy Yes

Trial Details

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.

Trial Number NCT05950711

Sponsors & Collaborators

Ohio State University
The Center for Psychedelic Drug Research & Education (CPDRE) at the College of Social Work at Ohio State University aims to explore and advance the research about psychedelic drugs and their effects, and to disseminate the knowledge about psychedelics.

Data attribution

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